510(k) Report

Devices descending from K051205

829 later devices reach Stryker Spine Avs Asl Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+7K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+7K201585Monterey AL Interbody SystemStryker Corporation202044
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+7K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+7K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+7K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+7K190885Elevation Spine Saber-C SystemElevation Spine201925—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181818Scarlet AL-TSpineart201864—
+7K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+7K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+7K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+7K163595IMPIX 3D Print CagesMedicrea International SA2017282
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+7K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+7K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+7K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+7K161379ELSA SpacersGlobus Medical, Inc.2016155—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K152622Alta ACDF SystemBiomet Spine20160—
+7K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261049Scala® TLSpineart SA20260—
+8K261408SABER-XA SystemElevation Spine20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K260660SABER-C SystemElevation Spine20261—
+8K253260ORIO-3D Cage SystemSpineCraft20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K250540SABER-C SystemElevation Spine20252—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242589Scarlet® AL-TSpineart SA20240—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—