510(k) Report

Devices descending from K122226

225 later devices reach Revere Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222698CUVIS-spineCurexo, Inc.20220—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182182YUKON OCT Spinal SystemK2m20185—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+5K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K200896Solstice CCILife Spine, Inc.20200—
+5K193129Yukon OCT Spinal SystemK2m, Inc.202001
+5K183381Navigation Enabled InstrumentsStryker20191—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—