510(k) Report

Devices descending from K984377

672 later devices reach Synthes Spine Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240392JAZZ Spinal SystemImplanet20241—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K232167VySpan™ PCT SystemVy Spine, LLC20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+6K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K190751Connector SystemOrthofix, Inc.20193—
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—
+6K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+6K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+6K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+6K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+6K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+6K150753OASYS SystemStryker Corporation201534—
+6K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—