510(k) Report

Devices descending from K023835

1,227 later devices reach Devex Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K172065Scarlet AC-TSpineart20172—
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K171519FLXfit™Expanding Orthopedics, Inc.2017711
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K162531Sterispine CCSafe Orthopaedics20160—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153621Juliet® TiSpineart2016751
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K143143Pathway ElifCustom Spine, Inc.201514—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K142030STGC-LordoticCardinal Spine, LLC201558—
+4K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+4K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+4K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+4K133200Stalif C (R)Centinel Spine, Inc.201410—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K133207Staxx (R) SystemSpine Wave, Inc.20131—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K130254Prow FusionNlt Spine, Ltd.20138—
+4K131636Polarus ConnectAcumed, LLC20130—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+4K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+4K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+4K123913Latis SpacerGlobus Medical, Inc.201388—
+4K122097Patriot SpacersGlobus Medical, Inc.2012261—
+4K122021Sterispine LC CageSafe Orthopaedics20122—