510(k) Report

Devices descending from K003836

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K171140Matrixx SystemNexxt Spine, LLC2017145—
+7K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+7K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+7K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+7K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+7K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+7K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+7K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160631Keos Lumbar IBFDKeos20161—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+7K153436LATERAL Spine Truss System4Web, Inc.20165—
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+7K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K141896Coroent SystemNu Vasive, Incorporated2014480—
+7K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+7K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+7K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—