510(k) Report

Devices descending from K003275

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+7K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+7K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+7K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+7K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+7K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+7K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+7K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+7K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+7K162587Roccia® AcifSilony Medical GmbH20171—
+7K162531Sterispine CCSafe Orthopaedics20160—
+7K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+7K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+7K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+7K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+7K153621Juliet® TiSpineart2016751
+7K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+7K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+7K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+7K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+7K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+7K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+7K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K151727Everest Spinal SystemK2m, Inc.201511—
+7K151756Sterispine LC CageSafe Orthopaedics20150—
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+7K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+7K142744Mecta-C TiPEEKMedacta International201512—
+7K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+7K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+7K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+7K142360Everest Spinal SystemK2m, Inc.201522—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+7K142277Juliet POSpineart2014119—
+7K141791Biomet Fusion SystemBiomet Spine2014128—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+7K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+7K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+7K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+7K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+7K141147Range Spinal SystemK2m, Inc.20141—
+7K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+7K133200Stalif C (R)Centinel Spine, Inc.201410—
+7K140474Juliet OLSpineart2014120—
+7K132738Cogent Med-LifCogent Spine, LLC201413—
+7K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+7K133893Sterispine LC CageSafe Orthopaedics20141—
+7K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+7K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+7K133192Mectalif TipeekMedacta International201416—
+7K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+7K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+7K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+7K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+7K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+7K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+7K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+7K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+7K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+7K131547Lanx Fusion SystemLanx, Inc.20131631
+7K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+7K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+7K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+7K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+7K122047Alamo PAlliance Partners, LLC20120—
+7K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+7K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+7K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+7K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+7K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+7K111569Plateau Spacer SystemLife Spine2011181—
+7K110927MectalifMedacta International2011301
+7K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+7K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+7K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—