510(k) Report

Devices descending from K003043

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K131178Idys Lif CagesClariance201311—
+5K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K130461Stalif XCentinel Spine, Inc.201313—
+5K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+5K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+5K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+5K121178Transcorp Acif SystemTranscorp, Inc.20130—
+5K131372Mobis IISignus Medizintechnik GmbH2013462—
+5K130434Octane Straight, Octane Straight - Lordotic, Octane Straight I/R, Octane Straight I/R -…Exactech, Inc.201311—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K123134Easyspine SystemLdr Spine USA, Inc.20131—
+5K122097Patriot SpacersGlobus Medical, Inc.2012261—
+5K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+5K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+5K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+5K120401Alamo TAlliance Partners, LLC20121—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+5K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+5K113138Aleutian SystemK2m, Inc.2012549—
+5K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+5K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+5K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+5K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+5K111484DiscoveryIntuitive Spine, LLC20111—
+5K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+5K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+5K110177Helena SystemRoyal Oak Medical Devices20110—
+5K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+5K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+5K100698STCCCardinal Spine, LLC2011346—
+5K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+5K102293Caliber SpacerGlobus Medical, Inc.2011869—
+5K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+5K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+5K101288Staxx XD SystemSpine Wave, Inc.201051
+5K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+5K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+5K071726ZUMASeaspine, Inc.200712—
+5K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+5K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+5K053292Davantis/Antelys Vertebral Body ReplacementsScient'X USA, Inc.20060—
+5K052096Nubic Spinal ImplantSignus Medical, LLC2005790—
+5K051454Aleutian Spacer SystemK2m, LLC2005666—
+5K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K261049Scala® TLSpineart SA20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—