510(k) Report

Devices descending from K950709

541 later devices reach Synergy TI Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+7K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+7K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+7K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K131833Centurion Poct SystemOrthofix, Inc.20142—
+7K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+7K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+7K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+7K130176Firebird Spinal Fixation SystemOrthofix20135—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+8K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240963Spinal SystemTeslake, Inc.20240—
+8K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+8K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+8K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+8K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+8K230026SqualeImplanet, S.A.20230—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+8K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+8K190376PASS LP Spinal SystemMedicrea International SA201915
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K172194Connector SystemOrthofix, Inc.2017162
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+8K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+8K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+8K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+8K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+8K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+8K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+8K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+9K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—