510(k) Report

Devices descending from K020522

1,234 later devices reach Modification to Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K153621Juliet® TiSpineart2016751
+5K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K143479Bluefin Interbody SystemTides Medical20152—
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K151654Prow FusionNlt Spine, Ltd.20151—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+5K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+5K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+5K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+5K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+5K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+5K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+5K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+5K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+5K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+5K140411Altera SpacerGlobus Medical, Inc.201419122
+5K133200Stalif C (R)Centinel Spine, Inc.201410—
+5K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+5K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+5K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+5K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+5K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+5K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+5K123231Caliber SpacersGlobus Medical, Inc.2013657—
+5K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+5K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K120101Independence SpacerGlobus Medical, Inc.2012224—
+5K113447Rise SpacerGlobus Medical, Inc.2012691—
+5K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+5K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+5K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—