510(k) Report

Devices descending from K003275

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+6K140280ForticoreNanovis, LLC20149—
+6K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+6K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+6K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+6K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K140303Alamo TAlliance Partners, LLC20140—
+6K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+6K133614Aleutian Ibf SystemK2m, Inc.2014527—
+6K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+6K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+6K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+6K133967Interbody Cage SystemAurora Spine2014227—
+6K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+6K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K130853Idys (TM) CClariance20132—
+6K131178Idys Lif CagesClariance201311—
+6K132361Everest Spinal SystemK2m, Inc.201334—
+6K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+6K131671MectalifMedacta International201322—
+6K130699Aleutian Spinal SystemK2m, Inc.2013570—
+6K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+6K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+6K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+6K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+6K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+6K123767Lanx Fusion System- SALanx, Inc.20133244
+6K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+6K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+6K120603Varilift -CWenzel Spine2013193—
+6K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+6K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+6K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+6K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+6K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+6K122021Sterispine LC CageSafe Orthopaedics20122—
+6K120819Stalif CCentinel Spine, Inc.2012206—
+6K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+6K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+6K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+6K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+6K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+6K113478Plif CageEisertech, LLC2012269—
+6K112862Mecta-CMedacta International201114—
+6K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+6K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+6K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+6K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+6K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+6K110915Cervical CageEisertech, LLC201123—
+6K103111Forza Spacer SystemOrthofix, Inc.20113431
+6K103169AleuttianK2m, Inc.2011572—
+6K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+6K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+6K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+6K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+6K100889Endoskeleton TCTitan Spine, LLC2010455—
+6K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+6K101302Aleutian Ibf SystemK2m, Inc.2010595—
+6K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+6K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+6K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+6K073502Vertebron VBR SystemVertebron, Inc.200812—
+7K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261430TruLift Expandable SystemLife Spine, Inc.20260—
+7K2530413d Cage CervicalFims Co., Ltd.20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K261067BEE PLIF CageNGMedical GmbH20260—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251016MectaLIF 3D MetalMedacta International S.A.20250—
+7K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—