510(k) Report

Devices descending from K072253

1,250 later devices reach Synfix-LR Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K200312Tryptik TiSpineart20202—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+3K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K181048Neo Cage System TMNeo Medical SA20191—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181818Scarlet AL-TSpineart201864—
+3K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+3K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K181203Juliet TiSpineart20181—
+3K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K173702Juliet Ti LLSpineart20182—
+3K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+3K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+3K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+3K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+3K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+3K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+3K161129Pillar SA PTCOrthofix, Inc.201619—