510(k) Report

Devices descending from K003275

1,705 later devices reach Synthes Synmesh Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173128Alamo® CAlliance Partners, LLC20182—
+8K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K172756Varian cageMedyssey USA, Inc.20171—
+8K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+8K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+8K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+8K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+8K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+8K171425Concorde LiftMedos International SARL201782
+8K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+8K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+8K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+8K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+8K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+8K161028K2M Growing Spine SystemK2m, Inc.20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160631Keos Lumbar IBFDKeos20161—
+8K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+8K153436LATERAL Spine Truss System4Web, Inc.20165—
+8K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+8K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+8K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+8K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+8K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+8K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+8K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+8K151216Everest Spinal SystemK2m, Inc.201511—
+8K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+8K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+8K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+8K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+8K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+8K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+8K143616AccuLIF TL and PL CageStryker Corporation20154694
+8K141187Impix Alif S/aMedicrea International SA201501
+8K141896Coroent SystemNu Vasive, Incorporated2014480—
+8K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+8K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+8K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+8K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+8K1421124WEB Spinal Implant Products4Web, Inc.201433—
+8K133402K2M Modular HooksK2m, Inc.20140—
+8K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+8K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+8K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+8K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+8K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+8K130461Stalif XCentinel Spine, Inc.201313—
+8K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+8K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+8K120869Anchor-L Lumbar CageStryker Spine2012638—
+8K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+8K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+8K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+8K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+8K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+8K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+8K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+8K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+8K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+8K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+8K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+8K103369Vault Alif SystemSpinal USA201110—
+8K093093Small Plateau Spacer SystemLife Spine2010393—
+8K101301Stalif MidlineCentinel Spine2010474—
+8K083475Lucent MagnumSpinal Elements, Inc.2009834—
+8K081711Lucent Magnum+Spinal Elements, Inc.20080—
+9K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K252322SIros-X SystemGenesys Spine20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K210728CONDUIT InstrumentsMedos International SARL20215—