510(k) Report

Devices descending from K093294

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+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—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+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—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+9K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+9K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—