510(k) Report

Devices descending from K062083

1,252 later devices reach Synfix -LR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141187Impix Alif S/aMedicrea International SA201501
+1K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+1K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+1K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+1K071726ZUMASeaspine, Inc.200712—
+1K072253Synfix-LR SpacerSynthes Spine Co.Lp20071,2501
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K181963ostaPek Interbody Fusion CagesColigne AG20181—
+2K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+2K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+2K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K142271Zavation Z-Link LumbarZavation, LLC20149—
+2K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+2K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+2K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+2K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+2K124034Mectalif AnteriorMedacta International201311—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+2K102738Lanx Fusion SystemLanx, LLC20113281
+2K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+2K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+2K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC2010113—
+2K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+2K081888Dynamik Intervertebral Body Fusion DeviceSpineart2009282—
+2K081196Spinal Usa VBR SystemSpinal USA200813—
+2K081636Peek-Optima Alif SpacerBiomet Spine2008542—
+2K081395Solitaire Peek-Optima Anterior Spinal SystemBiomet Spine2008854—
+2K080673Interfuse Intervertebral Body Fusion DeviceVertebral Technologies, Inc.2008103—
+2K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+2K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+2K073470Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine20081,102—
+2K072981Synthes Zero-PSynthes Spine Co.Lp20085462
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+3K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+3K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K153621Juliet® TiSpineart2016751
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K152200SurgTech Interbody SystemSurgtech, Inc.20160—