510(k) Report

Devices descending from P950002

1,681 later devices reach Bak Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+3K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+3K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K163180Hubble IIOrbbo Surgical, LLC20160—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K153621Juliet® TiSpineart2016751
+3K160631Keos Lumbar IBFDKeos20161—
+3K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+3K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+3K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+3K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+3K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+3K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+3K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+3K142504SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc.20154—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K142456GPS SpacersG Surgical, LLC20151—
+3K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K142328nvcNvision Biomedical Technologies, LLC20144—
+3K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+3K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+3K141942Midline II TICentinel Spine, Inc.2014459—
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K142277Juliet POSpineart2014119—
+3K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K1421124WEB Spinal Implant Products4Web, Inc.201433—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K140280ForticoreNanovis, LLC20149—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K140564BN Lumbar Cage SystemMedyssey USA, Inc.20143—
+3K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+3K140303Alamo TAlliance Partners, LLC20140—