510(k) Report

Devices descending from K001470

190 later devices reach E-Z Link Cross Connector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+7K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K220025ARx® Spinal SystemLife Spine, Inc.20220—
+8K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+8K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+8K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+9K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+9K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—
+10K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+10K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+10K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K210549ARx Spinal SystemLife Spine, Inc.20211—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+11K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—