510(k) Report

Devices descending from K051027

908 later devices reach Stalif TT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+1K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+2K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+2K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+2K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+2K161129Pillar SA PTCOrthofix, Inc.201619—
+2K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+2K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+2K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+2K141187Impix Alif S/aMedicrea International SA201501
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+2K132596Proposed OptimusCustom Spine, Inc.201451
+2K133286Midline (TM)Centinel Spine, Inc.2014460—
+2K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+2K130461Stalif XCentinel Spine, Inc.201313—
+2K124034Mectalif AnteriorMedacta International201311—
+2K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+2K120869Anchor-L Lumbar CageStryker Spine2012638—
+2K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+2K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+2K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+2K103369Vault Alif SystemSpinal USA201110—
+2K101301Stalif MidlineCentinel Spine2010474—
+2K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+2K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+2K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+2K083475Lucent MagnumSpinal Elements, Inc.2009834—
+2K081711Lucent Magnum+Spinal Elements, Inc.20080—
+3K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K203003Pantheon IBFDPantheon Spinal20210—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192993Scarlet AL-TSpineart20201—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+3K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181818Scarlet AL-TSpineart201864—
+3K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701