510(k) Report

Devices descending from K964159

281 later devices reach CD Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+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—
+5K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+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—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K203023Pisces Spinal SystemOrtho Development Corporation20210—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+6K131833Centurion Poct SystemOrthofix, Inc.20142—
+6K132603Apex Spine SystemSpinecraft, LLC201325—
+6K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+6K130176Firebird Spinal Fixation SystemOrthofix20135—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—