510(k) Report

Devices descending from K914306

580 later devices reach TSRH (TM) Lateral Offset Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+5K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+5K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+5K162143FixxSure® X-LinkInnovasis, Inc.20160—
+5K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+5K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K120047Coral Spinal SystemTheken Spine, LLC201214—
+5K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+5K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+5K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+5K081331Fixxsure Cross LinkSpineworks, LLC200891—
+5K080767Conquest Spinal SystemLife Spine200821—
+5K072605Malibu Spinal SystemSeaspine, Inc.200767—
+5K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+5K061321Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XXAlphatec Spine, Inc.20060—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+6K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—