510(k) Report

Devices descending from K073470

1,102 later devices reach Avs PL Peek Spacers, Models 48351XXX and 48353XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+4K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181818Scarlet AL-TSpineart201864—
+4K181397DualXInnovasive, Inc.201815—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K171312FortiCore®Nanovis, LLC20183—
+4K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+4K173702Juliet Ti LLSpineart20182—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+4K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162262Tritanium® PL CageStryker2016132—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K160955Tritanium® PL CageStryker2016178—
+4K153621Juliet® TiSpineart2016751
+4K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—