510(k) Report

Devices descending from K043479

1,214 later devices reach MC+ Partial VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K171312FortiCore®Nanovis, LLC20183—
+3K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+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—
+3K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+3K152568C-VBRCardinal Spine, LLC201657—
+3K151939COALITION SpacersGlobus Medical, Inc.2016152—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+3K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+3K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+3K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+3K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+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—
+3K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+3K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+3K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+3K142392Zavation Posterior LEIFZavation, LLC20150—
+3K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+3K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K142030STGC-LordoticCardinal Spine, LLC201558—
+3K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K142271Zavation Z-Link LumbarZavation, LLC20149—
+3K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+3K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K140280ForticoreNanovis, LLC20149—
+3K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140303Alamo TAlliance Partners, LLC20140—
+3K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+3K133614Aleutian Ibf SystemK2m, Inc.2014527—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+3K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+3K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K130853Idys (TM) CClariance20132—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+3K131671MectalifMedacta International201322—
+3K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+3K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+3K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+3K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+3K123134Easyspine SystemLdr Spine USA, Inc.20131—
+3K120603Varilift -CWenzel Spine2013193—
+3K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+3K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+3K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+3K122021Sterispine LC CageSafe Orthopaedics20122—
+3K120819Stalif CCentinel Spine, Inc.2012206—
+3K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+3K112862Mecta-CMedacta International201114—
+3K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+3K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+3K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+4K2530413d Cage CervicalFims Co., Ltd.20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—