Cd horizon spinal system

Cd horizon spinal system. 5/6 MAS 6. 5mm rods and associated components may be used for the Oct 31, 2022 · AccessGUDID - CD HORIZON® Spinal System (00643169754638)- DOMINO 5135251 VARIABLE ANGLE 5. Brand Name: CD Horizon™ ModuLeX™ Spinal System. Further evaluation of the tapped pedicle can be performed by using the NIM-ECLIPSE™ Spinal System and the Surgeon- Oct 19, 2015 · CD HORIZON PEEK RODS System uses rods made of polyetheretherketone, a semi-crystalline thermoplastic polymer that meets all biocompatibility requirements and has a long history of use in surgical implants. FDA 510(k) clearance in 2003 and a second 510(k) clearance in April 2005. Version or Model: 848-011. , Memphis, TN, USA) were compared. 0MM RODS, REF 55840005045. May 14, 2015 · CD Horizon Solera Voyager is a spinal system designed for minimally invasive spine procedures. Nov 13, 2021 · Fully-enabled rod and modular screw system for posterior lumbar fixation. 5mm dia x 100mm, size: 15mm x 100mm, for spinal fixation. Primary DI Number: 00643169768291. Dec 14, 2011 · The purpose of this study is to evaluate the feasibility of using the investigational implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral lumbar spinal fusion at two adjacent treatment levels in patients with symptomatic degenerative disc disease. Version or Model: 2950006. Paul Harrington in the late 1960’s, pedicle screws have gone through multiple phases and changes. The CD HORIZON® Spinal System is available in either titanium or stainless steel. The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma Apr 14, 2018 · The CD HORIZON® SOLERA™ System is the first platform technology that enables surgeons to confidently and efficiently treat their patients by using: high strength, low profile multi-axial screws designed for use with multiple rod types. Version or Model: 55900105550. The CD Horizon ModuLeX 5. 5 mm rod sizes. Commercial Distribution End Date: Jul 8, 2015 · Medtronic has launched the CD Horizon Solera Voyager spinal system for minimally invasive spine procedures. 11/21/2011). MULTI-AXIAL SCREW FOR 5. For several indications, pedicle screws are currently viewed as a needed addition for spinal fusion due to the immediate fixation they provide. Commercial Distribution End Date: Aug 10, 2020 · Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. Primary DI Number: 00721902303906. Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. Code Information. 0mm Multi‒Axial Reductionスクリューの機能を損なわず、経皮的なロッド挿入を可能にし たTab Extenderシステムです。 CD Horizon Spinal System Instruments: Applicant: Medtronic Sofamor Danek USA, INC. Primary DI Number: 00643169754577. CD Horizon® SpinaL SySTeM MULTi aXiaL SCreW preface Since first used by Dr. Request updates about the Medtronic CD Horizon™ ModuLeX™ 5. With the CD Horizon Solera Voyager System, surgeons have the flexibility to use either a percutaneous or Wiltse A minimally invasive pedicle screw system based on CD Horizon Solera Spinal System platform technology. High-strength, low-profile multi-axial screws. Lenke has abundant design and working knowledge of the intricacies of the SOLERA System and how it can benefit his patients. Brand Name: CD HORIZON® SOLERA® VOYAGER™ Spinal System. Brand Name: CD Horizon® Ballast™ Spinal System. CD HORIZON LONGITUDE™ Multi-Level Percutaneous Fixation System 17 STEP 10 | TAP PEDICLE The pedicle is prepared by placing the Tap over the Guidewire and through the third Dilator (Figure 20). "I am furious," says Richard, "because I need to go through another surgery to take it out and a Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. CD HORIZON Legacy 5. I have read and agree with the Terms and Conditions *(opens new window). More Facts The CD Horizon Legacy Spinal System Jul 11, 2013 · Thomson Reuters ONE via COMTEX) --MEMPHIS, Tenn. Performance. Brand Name: CD HORIZON® SOLERA® Spinal System. Commercial Distribution End Date: CD HORIZON® Spinal System The subject devices have identical indications to the most recently cleared CD HORIZON® Spinal System indications in K162379 (S. The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies The CD HORIZON® SOLERA® 4. 0mm to Ø7. Care should be taken so the correct components are used in the spinal construct. 5 CCM NS CURV 50MM Pedicle screw spinal system, adolescent idiopathic scoliosis MNH Jul 6, 2018 · Device Identifier (DI) Information. 5 CCM NS CURV 60MM Pedicle screw spinal system, adolescent idiopathic scoliosis NKB AccessGUDID - CD HORIZON® Spinal System (00643169004337)- SCREW 55840007540 5. It is made of titanium or implantable-grade stainless steel. The CD HORIZON SPIRE Spinal System received original U. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. Efficiency. The SAS features a fixed head made of cobalt chrome Jul 6, 2018 · Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. 75mm, 5. With the exception of DDD, the CD Horizon™ LEGACY™ 3. 5mm to Ø8. When combined with CD HORIZON® Spinal System-based pedicle screws and minimally invasive approach options such as the MAST QUADRANT™ Retractor Set, the CD HORIZON LEGACY PEEK [] AccessGUDID - CD HORIZON® Spinal System (00643169133709)- CONN X1211040 MRC 5. 35 CLS LAT 10 TI Pedicle screw spinal system, adolescent idiopathic scoliosis AccessGUDID - CD HORIZON® Spinal System (00643169081260)- ROD 1555501060 5. Sep 5, 2019 · The CD Horizon™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each construct being tailored to the individual case. Proposed Proprietary Trade Name: CD HORIZON® Spinal System III. The system is available in multiple rod diameters and screw sizes so your surgeon can choose the appropriate size for your condition, anatomy, and activity level. With the exception of DDD, CD Horizon™ Legacy™ 3. The CD Horizon Legacy Spinal System is made out of titanium or stainless steel implantable grade metal. Version or Model: 55900205540. The CD HORIZON ® LEGACY™ Spinal System was designed by Dr. Aug 23, 2016 · The primary predicate for the CD HORIZON® Solera™ Spinal System is the predicate . Version or Model: 55850016555. Version or Model: 55850016550. The CD Horizon Legacy Spinal System consists of rods, hooks, and screws for implantation in the spine to correct the abnormal curvature. Summary of background data: Plates and pedicle screw/rod and facet screw implants are Introduction: For the treatment of unstable non-osteoporotic thoracolumbar fractures, the clinical and radiological outcome of short-segment fixation with the USS™ - Universal Spine System (DePuy Orthopedics, Inc. To-date there have been over 500,000 surgeries performed with the CD Horizon Legacy Spinal System. The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma on the CD Horizon™ spinal system Indications The CD Horizon ™ spinal system with or without Sextant instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. Dr. By Jane Mundy. Oct 19, 2018 · Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. AccessGUDID - CD HORIZON® Spinal System (00613994971746)- SCREW 55840006540 5. This offering allows for construct extensions laterally and medially for 【公式】メドトロニックが提供する医療従事者向けサイトの製品情報ページです。CD Horizon™ Ballast™の情報を掲載しています。日本国内の医療従事者を対象に、医療機器を適正にご使用いただくための情報を提供しています。 Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. , pedicle-based screws and rods), the CD Horizon™ Spire™ spinal system is not CD Horizon Solera Voyager System expands upon the transforaminal lumbar interbody fusion (TLIF) procedure by offering multiple, minimally invasive rod insertion options and enabling a seamless 3D-navigated surgical experience. The CD Horizon™ spinal system with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies Through the process of developing this complex implant system Dr. 2 09/11/2008 Medtronic Sofamor Danek USA Inc - - and compression of the bone graft, is CT/MRI compatible, and easy to implant. 5mm Spinal System. Lenke is one of the key developers of the new generation of spinal systems called the CD HORIZON® SOLERA™ Spinal System. 5 6. The CD Horizon™ Astute™ Device Identifier (DI) Information. Available in 4. Request information. 5 Spinal System is compatible with all 5. The CD HORIZON® SOLERA® 5. medtron The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of Apr 14, 2018 · The CD Horizon Legacy Spinal System has been used to treat scoliosis since 2004. the first-ever powered instruments being developed specifically for spinal implants. The system allows both percutaneous and Wiltse minimally invasive rod insertion and features a low-profile, extended-tab screw with inner threading, Medtronic said Jul 6, 2018 · Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. Primary DI Number: 00643169768277. The CD HORIZON ANTARES Spinal System consists of unique vertebral body staples, CROSSLINK® Plates, and anterior instruments used in conjunction with a variety of CD HORIZON M8 Spinal System screws and rods to create a highly-versatile anterior fixation system. 0 Pedicle screw spinal system, adolescent idiopathic scoliosis MNH Jul 9, 2018 · Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine. 5 rods and integrated with advanced technologies. Commercial Distribution End Date: Nov 29, 2019 · Introduction: For the treatment of unstable non-osteoporotic thoracolumbar fractures, the clinical and radiological outcome of short-segment fixation with the USS™ – Universal Spine System (DePuy Orthopedics, Inc. 5mm Ø5. Your information will be used and protected in accordance with our privacy statement (opens new window). For more information, healthcare professionals may visit https://www. 5mm Ø4. Jun 30, 2008 · The posterior spinal fixation system, the CD HORIZON® Spinal System, is a commercially available rod-based spinal system intended for temporary stabilization of the spine in order to facilitate fusion. Version or Model: 651003035. The CD HORIZON™ Spinal System with or without SEXTANT™ instrumentation is intended for posterior, noncervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies With its dedication to pioneering spine surgery solutions for revision, deformity and trauma surgeries, Medtronic has added the dual rod multi-axial screw (DRMAS) to enhance the versatility and efficiency of any current CD Horizon™ Solera™ 5. With instrumentation, a listing of potential adverse events includes. Compatible with Navigation and Power. , Memphis, TN, USA) were Bone-screw internal spinal fixation system, sterile An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. Z-1417-2008 - Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901500, 15mm, 5. Find indication, safety and warning information for the CD HORIZON Spinal System from Medtronic. Primary DI Number: 00763000436018. The CD HORIZON@ Spinal System consists of a variety of rods, hooks, screws, CROSSLINK@ plates, staples, and other connecting components, as well as implant components from other Medtronic Sofamor Danek spinal systems, which can be rigidly locked in a variety of Bone-screw internal spinal fixation system, sterile An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. 5 Spinal System, (Medtronic Sofamor Danek USA, Inc. 5 SET SCREW Device Identifier (DI) Information. Mar 7, 2023 · Learn how two neurosurgeons use and benefit from the modular screw system that offers increased visualization and versatility in spinal surgery. 5 Deformity. Primary DI Number: 00643169747975. Commercial Distribution End Date: Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. Sep 4, 2023 · The CD Horizon Legacy Spinal System is a series of rods, hooks, and screws implanted during spinal surgery, to correct scoliosis or abnormal side-to-side curvature of the spine. From the thoracic spine to the ilium, the CD HORIZON® SOLERA® Spinal System facilitates surgeon choice and flexibility across patient types with a variety of implant options for treating multiple spinal pathologies with one system family. Commercial Distribution Status: In Commercial Distribution. Available in countries around the world, the system expands upon the transforaminal lumbar interbody fusion procedure by offering multiple, minimally invasive rod insertion options and enabling a seamless 3D-navigated surgical experience. 0 Spinal System offers the opportunity to reduce overall metal mass and profile, and provide surgeon choice without compromising implant integrity, as seen in mechanical testing when compared to the CD HORIZON® LEGACY Device Identifier (DI) Information. - July 11, 2013 - Medtronic, Inc. 5X50 CC Pedicle screw spinal system, adolescent idiopathic scoliosis MNH Sep 16, 2022 · AccessGUDID - CD HORIZON® Spinal System (00643169200197)- CADDY 7064903 CDHL II 5. 5 spinal system offers improved in-situ visualization, intra-operative flexibility, and procedural efficiencies, allowing you to complete posterior lumbar fixation procedures with confidence. Aug 1, 2016 · Objective: The aim of this study was to evaluate the biomechanics of lumbar motion segments instrumented with the CD HORIZON Spire Z plate system (Spire Z), a posterior supplemental fixation spinous process plate, alone and with additional fixation systems. Osteogrip™ dual-lead threadform. Jun 1, 2022 · This animation shows an overview of the CD Horizon ModuLeX™ 5. 5mm rods and associated components may be used for These modern implantable surgical systems can help correct spinal deformities, facilitate spinal fusion, and stabilize and strengthen the spine. 5mm to Ø10. Catalog Number: Company Name: MEDTRONIC SOFAMOR DANEK, INC. E. AccessGUDID - CD Horizon™ ModuLeX™ Spinal System (00763000865610)- TRAY 5598939 RATCHET NAV DRIVER TRAY Device Identifier (DI) Information. 5/6 MAS 7. 0 spinal rod system. Version or Model: 55850016545. , Warsaw, IN, USA) and the CD HORIZON ® LEGACY™ 5. 0mm Screw Lengths From 25mm to 100mm with a 5mm increment AccessGUDID - CD HORIZON® Spinal System (00643169081246)- ROD 1555501050 5. lot 0648247W. Profile. For this study, only titanium implant components will be used. Denver, CO :Richard had a CD Horizon spinal system Medtronic device implanted two years ago, just around the time the FDA recalled all lots of the MedTronic CD Horizon Spinal System Agile Dynamic Stabilization Device. 5X40 CC Pedicle screw spinal system, adolescent idiopathic scoliosis MNH Device Identifier (DI) Information. CD HORIZON® Spinal System (K113174, S. Commercial Distribution End Date: AccessGUDID - CD HORIZON® Spinal System (00613994971760)- SCREW 55840006550 5. Jul 6, 2018 · Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. * Indicates a required field. 5/6. The CD HORIZON™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade Discover the CD Horizon™ Solera™ Spinal System with Dual Rod Multi-Axial Screw (DRMAS) and Variable Angle Domino (VAD) Spinal System CD Horizon Solera Voyager 4. 35 REV OPEN TI Acquisition System O-arm Imaging System Clydesdale Spinal System Navigated Interbody Inserter Navigated CD Horizon Solera Voyager System with IPC™ Powerease™ System Navigated Stealth-Midas™ Powered Drilling System Direct Lateral Dilator with MAST™ Dilator Tracker and Stimulating Adapter Clip AccessGUDID - CD HORIZON® Spinal System (00885074030135)- CONNECTOR 7041310 5. Backed by 20+ years of proven CD Horizon™ technology, the ModuLeX™ 5. Primary DI Number: 00643169523852. Version or Model: 6550016. Primary DI Number: 00763000435530. , for degenerative disc disease (DDD)]. Commercial Distribution End Date: . 11/16/2016) The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as Jul 6, 2018 · Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. CD Horizon™ ModuLeX™ 5. S. 5mm rods and associated components may be used for the When combined with CD HORIZON® LEGACY™ System pedicle screws and a minimally invasive surgical approach, such as the MAST QUADRANT™ Retractor Set, the CD HORIZON® AGILE™ Device dynamically stabilizes the affected segment while allowing a streamlined surgical technique designed to preserve the natural anatomy. 1800 Pyramid Place: Memphis, TN 38132 Applicant Contact: Erikka Edwardsen: The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma The CPT codes listed below may be appropriate for the insertion of the CD Horizon™ Spire™ spinal system. The Horizon Solera Voyager offers multiple minimally invasive rod insertion options for transforaminal lumbar interbody fusion procedures. 5 spinal system. 5CL/6. 75 Spinal System is detailed in another technique UC201105109EE. Refer to the CD HORIZON™ Spinal System package insert for information regarding those implants. Brand Name: CD HORIZON® Spinal System. Primary DI Number: 00643169768284. 75 mm and 5. 5 spinal Jul 6, 2018 · Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. For individual cases where the CD Horizon™ Spire™ spinal system is placed in addition to either unilateral or bilateral posterior instrumentation (e. The subject CDHORIZON® Solera™ Spinal System screws have the same indications, similar intended use,and similar materials as the following FDA cleared predicates Jan 27, 2011 · “The launch of the CD HORIZON ® SOLERA ™ Spinal System is a key step in renewing our global fixation business, bringing new innovation to the market and extending our industry-leading The CD HORIZON SPIRE Spinal System may also reduce procedural costs and shorten the length of time a patient spends in an operating room. As the Next Generation CD HORIZON® Spinal System OCT 1 0 2008 510(k) Summary September 2008 1. 5X40 CC Pedicle screw spinal system, adolescent idiopathic scoliosis NKB October 1, 2009. Device Identifier (DI) Information. Commercial Distribution End Date: Aug 23, 2021 · Bone-screw internal spinal fixation system, sterile An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738 Contact: Brad Sheals Regulatory Affairs Specialist II. (NYSE:MDT) today announced the global market introduction of the CD HORIZON® SOLERA® Spinal System Sagittal Adjusting Screw (SAS) which may be used in the surgical correction of complex spinal pathologies. g. Lenke and colleagues in partnership with Medtronic Sofamor Danek, a world leader in the manufacture of spinal surgery systems. Issuing Agency: GS1. Commercial Distribution End Date: PASS LP Spinal System, Medicrea – New Components PASS LP Spinal System, Medicrea CD Horizon / Solera Spinal System, Medtronic MOSS Miami Spinal System, Depuy Polyaxial Iliac Screws Screw Diameters Ø4. db ph zl le qt xk lb kn ao jw