510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+8K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+8K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+8K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+8K153621Juliet® TiSpineart2016751
+8K152622Alta ACDF SystemBiomet Spine20160—
+8K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+8K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+8K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+8K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+8K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+8K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+8K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+8K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+8K160291Optimus ALIF SystemAmendia, Inc.20160—
+8K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+8K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+8K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+8K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+8K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+8K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+8K143479Bluefin Interbody SystemTides Medical20152—
+8K151727Everest Spinal SystemK2m, Inc.201511—
+8K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+8K151756Sterispine LC CageSafe Orthopaedics20150—
+8K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+8K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+8K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+8K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+8K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+8K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+8K142360Everest Spinal SystemK2m, Inc.201522—
+8K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+8K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+8K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+8K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+8K142277Juliet POSpineart2014119—
+8K141791Biomet Fusion SystemBiomet Spine2014128—
+8K1421124WEB Spinal Implant Products4Web, Inc.201433—
+8K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+8K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+8K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+8K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+8K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+8K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+8K141147Range Spinal SystemK2m, Inc.20141—
+8K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+8K133200Stalif C (R)Centinel Spine, Inc.201410—
+8K140474Juliet OLSpineart2014120—
+8K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+8K133893Sterispine LC CageSafe Orthopaedics20141—
+8K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+8K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+8K133192Mectalif TipeekMedacta International201416—
+8K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+8K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+8K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+8K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+8K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+8K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+8K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+8K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+8K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+8K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+8K131547Lanx Fusion SystemLanx, Inc.20131631
+8K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+8K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+8K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+8K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+8K122047Alamo PAlliance Partners, LLC20120—
+8K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+8K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+8K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+8K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+8K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+8K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+8K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+8K111569Plateau Spacer SystemLife Spine2011181—
+8K110927MectalifMedacta International2011301
+8K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+8K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+8K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+8K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+8K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+8K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+8K082801Phantom Plus Cage SystemUs Spine2008643—
+8K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+8K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+8K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+9K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261430TruLift Expandable SystemLife Spine, Inc.20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+9K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—