510(k) Report

Devices descending from K021009

184 later devices reach Octafix Occipital Cervical Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K152211PCT SystemCentinel Spine, Inc.20150—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.20153—
+6K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+6K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+7K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+7K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K180433Ennovate®Aesculap Implant Systems, LLC201811
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K223852VySpan™ PCT SystemVy Spine, LLC20231—
+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
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+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—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232167VySpan™ PCT SystemVy Spine, LLC20230—
+9K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+9K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+9K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—
+10K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)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—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+10K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+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—
+11K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+11K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+11K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+12K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—