510(k) Report

Devices descending from P000028

1,287 later devices reach Affinity (TM) Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+3K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG20170—
+3K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+3K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+3K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+3K163265Kepler IIOrbbo Surgical, LLC20170—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+3K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+3K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K152568C-VBRCardinal Spine, LLC201657—
+3K151939COALITION SpacersGlobus Medical, Inc.2016152—
+3K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+3K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+3K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+3K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+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—
+3K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+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—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+3K142392Zavation Posterior LEIFZavation, LLC20150—
+3K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+3K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+3K142030STGC-LordoticCardinal Spine, LLC201558—
+3K141187Impix Alif S/aMedicrea International SA201501
+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
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K140280ForticoreNanovis, LLC20149—
+3K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+3K140066Infill CervicalPinnacle Spine Group, LLC20140—
+3K140303Alamo TAlliance Partners, LLC20140—
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+3K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+3K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+3K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+3K133286Midline (TM)Centinel Spine, Inc.2014460—
+3K133321Alamo CAlliance Partners, LLC20143—
+3K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+3K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+3K130461Stalif XCentinel Spine, Inc.201313—
+3K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+3K131449Coalition SpacerGlobus Medical, Inc.2013235—
+3K131671MectalifMedacta International201322—
+3K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+3K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+3K124034Mectalif AnteriorMedacta International201311—
+3K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+3K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+3K123602TM Ardis Interbody System InserterZimmer Trabecular Metal Technology20131—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K120603Varilift -CWenzel Spine2013193—
+3K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+3K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+3K120869Anchor-L Lumbar CageStryker Spine2012638—
+3K122021Sterispine LC CageSafe Orthopaedics20122—
+3K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+3K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+3K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K112862Mecta-CMedacta International201114—
+3K113348Cougar SystemJohnson & Johnson2011591—
+3K111272Rhausler Plage Anterior Cervical Fusion SystemRhausler, Inc.20117—
+3K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—