510(k) Report

Devices descending from K003043

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K110915Cervical CageEisertech, LLC201123—
+4K100305Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…Icotec20118—
+4K111469Staxxsd SystemSpine Wave, Inc.20110—
+4K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+4K103743Concorde Curve SystemJohnson & Johnson20110—
+4K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+4K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+4K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+4K100889Endoskeleton TCTitan Spine, LLC2010455—
+4K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+4K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+4K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+4K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+4K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+4K090315Staxx XD SystemSpine Wave, Inc.20096—
+4K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+4K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+4K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+4K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+4K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+4K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+4K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+4K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+4K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+4K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+4K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+4K071274Gso GS1 SpacerGold Standard Orthopedics, LLC20070—
+4K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+4K061082Mobis Spinal ImplantSignus Medizintechnik GmbH20060—
+4K052170Seaspine VBR SystemSeaspine, Inc.200513—
+4K051659Semial Spinal ImplantSignus Medizintechnik GmbH2005790—
+4K050348CO Vertebral Body ReplacementScient'X20052—
+4K043316Rabea Spinal ImplantSignus Medizintechnik GmbH20051,005—
+4K042930Spacevision Cage SystemSpine Vision, Inc.20041,440—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250560BEE HANGMedical GmbH20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+5K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+5K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+5K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+5K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+5K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—