510(k) Report

Devices descending from K081636

542 later devices reach Peek-Optima Alif Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+1K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+1K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+1K082406Expandable Peek-Optima ImplantEbi, L.P.2009527—
+2K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+2K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+2K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+2K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+2K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+2K092574Esl Spinal SystemEbi, L.P.2010181—
+2K092336C-Thru Spinal SystemEbi, L.P.2009492—
+2K091381Ibex Spinal SystemEbi, L.P.2009181—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+3K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+3K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+3K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+3K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+4K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K130853Idys (TM) CClariance20132—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+4K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—