510(k) Report

Devices descending from K003836

1,330 later devices reach Synthes Synex Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+5K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+5K151939COALITION SpacersGlobus Medical, Inc.2016152—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+5K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+5K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+5K150481Cascadia Interbody SystemK2m, Inc.20154593
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K151654Prow FusionNlt Spine, Ltd.20151—
+5K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+5K142392Zavation Posterior LEIFZavation, LLC20150—
+5K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+5K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+5K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+5K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+5K142030STGC-LordoticCardinal Spine, LLC201558—
+5K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+5K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+5K142271Zavation Z-Link LumbarZavation, LLC20149—
+5K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+5K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+5K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+5K140280ForticoreNanovis, LLC20149—
+5K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+5K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+5K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140303Alamo TAlliance Partners, LLC20140—
+5K133614Aleutian Ibf SystemK2m, Inc.2014527—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+5K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+5K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K130853Idys (TM) CClariance20132—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+5K131671MectalifMedacta International201322—
+5K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+5K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+5K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K123134Easyspine SystemLdr Spine USA, Inc.20131—
+5K120603Varilift -CWenzel Spine2013193—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+5K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+5K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K120819Stalif CCentinel Spine, Inc.2012206—
+5K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+5K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+5K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+5K112862Mecta-CMedacta International201114—
+5K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+5K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+5K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261049Scala® TLSpineart SA20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—