510(k) Report

Devices descending from K031757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K163595IMPIX 3D Print CagesMedicrea International SA2017282
+6K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+6K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K172065Scarlet AC-TSpineart20172—
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+6K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+6K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+6K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+6K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+6K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+6K162587Roccia® AcifSilony Medical GmbH20171—
+6K162531Sterispine CCSafe Orthopaedics20160—
+6K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+6K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+6K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K153621Juliet® TiSpineart2016751
+6K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+6K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+6K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+6K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+6K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+6K160291Optimus ALIF SystemAmendia, Inc.20160—
+6K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+6K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+6K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+6K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+6K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K151756Sterispine LC CageSafe Orthopaedics20150—
+6K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+6K151654Prow FusionNlt Spine, Ltd.20151—
+6K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+6K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+6K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+6K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+6K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+6K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+6K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+6K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+6K142277Juliet POSpineart2014119—
+6K133717Longbow Spacer SystemLife Spine20149—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—