510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+3K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+3K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+3K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+3K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160528ANATOMIC PEEK PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201623—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K160291Optimus ALIF SystemAmendia, Inc.20160—
+3K152568C-VBRCardinal Spine, LLC201657—
+3K151939COALITION SpacersGlobus Medical, Inc.2016152—
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+3K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+3K143685Hedgehog Cervical Interbody Fusion DeviceVertera, Inc.201523—
+3K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+3K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+3K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+3K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K143740Battalion Universal Spacer SystemAlphatec Spine, Inc.2015247—
+3K150061Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc.2015135—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+3K142392Zavation Posterior LEIFZavation, LLC20150—
+3K142456GPS SpacersG Surgical, LLC20151—
+3K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+3K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K142030STGC-LordoticCardinal Spine, LLC201558—
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K142271Zavation Z-Link LumbarZavation, LLC20149—
+3K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+3K133827A-Link ZOsteo Vasive, LLC2014262
+3K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+3K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+3K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K140280ForticoreNanovis, LLC20149—
+3K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+3K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+3K140564BN Lumbar Cage SystemMedyssey USA, Inc.20143—
+3K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+3K140303Alamo TAlliance Partners, LLC20140—
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+3K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+3K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+3K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+3K133967Interbody Cage SystemAurora Spine2014227—
+3K133286Midline (TM)Centinel Spine, Inc.2014460—
+3K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+3K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+3K130461Stalif XCentinel Spine, Inc.201313—
+3K131449Coalition SpacerGlobus Medical, Inc.2013235—
+3K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+3K130699Aleutian Spinal SystemK2m, Inc.2013570—
+3K124034Mectalif AnteriorMedacta International201311—
+3K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+3K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+3K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+3K123602TM Ardis Interbody System InserterZimmer Trabecular Metal Technology20131—
+3K122967LucentSpinal Elements, Inc.2013615—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+3K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+3K120869Anchor-L Lumbar CageStryker Spine2012638—
+3K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+3K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+3K122021Sterispine LC CageSafe Orthopaedics20122—
+3K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+3K121246Medyssy LT Cage SystemMedyssey Co, Ltd.20122—
+3K121116Plateau Spacer SystemLife Spine201213—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+3K112388Lanx Cervical SALanx, Inc.201126—
+3K111272Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc.20117—
+3K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+3K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+3K103369Vault Alif SystemSpinal USA201110—
+3K103743Concorde Curve SystemJohnson & Johnson20110—