510(k) Report

Devices descending from K072415

948 later devices reach Stalif (TM) C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+1K192906Mecta-C Stand AloneMedacta International S.A.20201—
+1K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+1K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+1K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+1K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+1K133200Stalif C (R)Centinel Spine, Inc.201410—
+1K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+1K120819Stalif CCentinel Spine, Inc.2012206—
+1K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+1K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+1K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+1K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+2K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+2K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+2K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+2K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+2K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+2K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+2K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+2K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+2K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+2K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+2K162531Sterispine CCSafe Orthopaedics20160—
+2K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+2K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+2K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+2K160125Cascadia Interbody SystemK2m2016315—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+2K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+2K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+2K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+2K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+2K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+2K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+2K141187Impix Alif S/aMedicrea International SA201501
+2K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+2K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+2K140303Alamo TAlliance Partners, LLC20140—
+2K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+2K133286Midline (TM)Centinel Spine, Inc.2014460—
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+2K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+2K130461Stalif XCentinel Spine, Inc.201313—
+2K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+2K124034Mectalif AnteriorMedacta International201311—
+2K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+2K120869Anchor-L Lumbar CageStryker Spine2012638—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+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—
+2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K261279DeltaNEC Interbody SystemNexus Spine20260—
+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—
+3K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+3K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+3K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—