510(k) Report

Devices descending from P950002

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+1K181963ostaPek Interbody Fusion CagesColigne AG20181—
+1K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+1K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+1K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+1K143479Bluefin Interbody SystemTides Medical20152—
+1K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+1K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+1K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+1K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+1K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+1K102957Cutting Edge Spine Interbody Fusion DeviceCutting Edge Spine, LLC201193—
+1K110177Helena SystemRoyal Oak Medical Devices20110—
+1K083894Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC2011538—
+1K102067Endoskeleton toTitan Spine, LLC2010337—
+1K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+1K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+1K092901Epicage Interbody Fusion DeviceR Tree Innovations2010609—
+1K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC2010113—
+1K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+1K091122Diana Fusion CageSignus Medical20090—
+1K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008—
+1K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+1K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+1K090376Spinesmith Cynch Spinal SystemSpine Smith Partners L.P.2009476—
+1K082801Phantom Plus Cage SystemUs Spine2008643—
+1K080615Endoskeleton TA Interbody Fusion Device (Ibd)Titan Spine, LLC2008564—
+1K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+1K080058Turbo Prime Ibd SystemSpineselect, LLC20081—
+1K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+1K073202Ardis SpacerAbbott Spine, Inc.2008644Class I
+1K072226Impix SpacerMedicrea Technologies2007812—
+1K072289Spinefrontier Dorado VBRSpinefrontier, Inc.200717—
+1K072253Synfix-LR SpacerSynthes Spine Co.Lp20071,2501
+1K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+2K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+2K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+2K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+2K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+2K223251Hexanium PLIFSpinevision, S.A.S.20220—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+2K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+2K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+2K191796Neo Cage SystemNeo Medical SA20190—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+2K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage…Solco Biomedical Co., Ltd.20192—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+2K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+2K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K181048Neo Cage System TMNeo Medical SA20191—
+2K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+2K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+2K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+2K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+2K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+2K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+2K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+2K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+2K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173148ACIFColigne AG20171—
+2K172424Velofix™ SA Cervical CageU&I Corporation201751
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+2K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+2K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+2K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG20170—