510(k) Report

Devices descending from K120486

224 later devices reach Avs as Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+1K162496Foundation 3D InterbodyCorelink, LLC201782—
+1K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+1K142251AVS AS PEEK SpacerStryker Corporation2014161—
+1K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+1K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+1K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+2K230329F3D Interbody SystemCorelink, LLC20230—
+2K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+2K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+2K230026SqualeImplanet, S.A.20230—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K183064TxTi IBF SystemInnovasis, Inc.2019481
+2K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+2K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K161407Ascential IBD PEEKc SpacerStryker Spine201627—
+2K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K242303MOD-COrthomod, LLC20260—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K223326Axiom PSR SystemRestor3D202301
+3K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+3K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+3K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K200312Tryptik TiSpineart20202—
+3K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+3K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K163265Kepler IIOrbbo Surgical, LLC20170—
+3K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+4K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250560BEE HANGMedical GmbH20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—