510(k) Report

Devices descending from P950002

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+4K172065Scarlet AC-TSpineart20172—
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+4K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+4K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163265Kepler IIOrbbo Surgical, LLC20170—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+4K162531Sterispine CCSafe Orthopaedics20160—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K151756Sterispine LC CageSafe Orthopaedics20150—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+4K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+4K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+4K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+4K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+4K141896Coroent SystemNu Vasive, Incorporated2014480—
+4K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+4K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+4K141791Biomet Fusion SystemBiomet Spine2014128—
+4K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+4K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+4K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+4K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated2014483—