510(k) Report

Devices descending from K080537

958 later devices reach L-Varlock through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181818Scarlet AL-TSpineart201864—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K181203Juliet TiSpineart20181—
+4K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+4K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+4K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+4K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K173702Juliet Ti LLSpineart20182—
+4K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160631Keos Lumbar IBFDKeos20161—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153436LATERAL Spine Truss System4Web, Inc.20165—
+4K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+4K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+4K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+4K141896Coroent SystemNu Vasive, Incorporated2014480—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+4K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+4K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—