510(k) Report

Devices descending from K003836

1,330 later devices reach Synthes Synex Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K201793EDEN Peek CageJmt Co., Ltd.20210—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K200919Idys ALIF 3DTiClariance20210—
+8K202032Idys LLIF 3DTiClariance, Sas20210—
+8K210359Hexanium TLIFSpinevision, S.A.S.20211—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+8K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+8K193174Keos Lumbar IBFDKeos20190—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K191263Idys ALIF TiVacClariance, Sas20190—
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+8K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K170235Lucent®Spinal Elements, Inc.2017107—
+8K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+8K171321K2M Navigation InstrumentsK2m201711
+8K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+8K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+8K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+8K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+8K152651AccuLIF TL and PL CageStryker Corporation201530—
+8K152304Tritanium PL CageStryker20154481
+8K141135Juliet LLSpineart2014146—
+8K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K223251Hexanium PLIFSpinevision, S.A.S.20220—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+9K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—