510(k) Report

Devices descending from K031757

1,702 later devices reach Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K172424Velofix™ SA Cervical CageU&I Corporation201751
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+5K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+5K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+5K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+5K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+5K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+5K152568C-VBRCardinal Spine, LLC201657—
+5K151939COALITION SpacersGlobus Medical, Inc.2016152—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+5K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+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—
+5K150481Cascadia Interbody SystemK2m, Inc.20154593
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+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—
+5K133827A-Link ZOsteo Vasive, LLC2014262
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+5K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K1421124WEB Spinal Implant Products4Web, Inc.201433—
+5K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+5K140280ForticoreNanovis, LLC20149—
+5K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K140303Alamo TAlliance Partners, LLC20140—
+5K132596Proposed OptimusCustom Spine, Inc.201451
+5K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+5K133614Aleutian Ibf SystemK2m, Inc.2014527—
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+5K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+5K133286Midline (TM)Centinel Spine, Inc.2014460—
+5K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K130853Idys (TM) CClariance20132—
+5K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+5K130254Prow FusionNlt Spine, Ltd.20138—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+5K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+5K131077Life Spine Plateau Spacer SystemLife Spine201310—
+5K131671MectalifMedacta International201322—