510(k) Report

Devices descending from K122037

281 later devices reach Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+1K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+1K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+1K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+1K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+1K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+1K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+2K261408SABER-XA SystemElevation Spine20260—
+2K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+2K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+2K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+2K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+2K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+2K172083Idys™ ALIF SystemClariance, Sas20177—
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+2K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+2K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+2K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+2K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K200919Idys ALIF 3DTiClariance20210—
+3K202032Idys LLIF 3DTiClariance, Sas20210—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+3K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+3K191134IB3D AlifMedicrea International SA20191—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K191263Idys ALIF TiVacClariance, Sas20190—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—