510(k) Report

Devices descending from K001668

450 later devices reach Global Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+6K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+6K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+6K123552Instinct Java SystemZimmer Spine201301
+6K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+6K112493Pass LP Spinal SystemMedicrea International20111—
+6K110497Pass LP Spinal SystemMedicrea International20111331
+6K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+6K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K153413PASS LP Spinal SystemMedicrea International SA20160—
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+7K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+7K123138Pass LP Spinal SystemMedicrea International2013132—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—