510(k) Report

Devices descending from K032064

1,280 later devices reach Theken Cpod/Lpod Vertebral Body Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K172065Scarlet AC-TSpineart20172—
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+5K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+5K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+5K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+5K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K162587Roccia® AcifSilony Medical GmbH20171—
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+5K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+5K153621Juliet® TiSpineart2016751
+5K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+5K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+5K153786Prow Fusion-VNlt Spine, Ltd.20166—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+5K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+5K151756Sterispine LC CageSafe Orthopaedics20150—
+5K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+5K151654Prow FusionNlt Spine, Ltd.20151—
+5K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+5K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K142744Mecta-C TiPEEKMedacta International201512—
+5K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+5K142277Juliet POSpineart2014119—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+5K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K133200Stalif C (R)Centinel Spine, Inc.201410—
+5K140474Juliet OLSpineart2014120—
+5K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+5K133893Sterispine LC CageSafe Orthopaedics20141—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K133192Mectalif TipeekMedacta International201416—