510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212831MectaLIF ExtensionMedacta International S.A.20211—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K193174Keos Lumbar IBFDKeos20190—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K192117Small VBR™Ulrich GmbH & Co. KG20196—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181963ostaPek Interbody Fusion CagesColigne AG20181—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181397DualXInnovasive, Inc.201815—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K172568CervagePrecifit Medical, Ltd.20181—
+4K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K173128Alamo® CAlliance Partners, LLC20182—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K172756Varian cageMedyssey USA, Inc.20171—
+4K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+4K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—