510(k) Report

Devices descending from K031757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K110843Aleutian Spacer SystemK2m, Inc.2011589—
+4K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+4K110177Helena SystemRoyal Oak Medical Devices20110—
+4K100698STCCCardinal Spine, LLC2011346—
+4K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+4K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+4K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+4K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+4K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+4K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+4K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+4K082698Aleutian Ibf SystemK2m, Inc.2009662—
+4K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+4K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+4K063399Aleutian Spacer SystemK2m, Inc.2007663—
+4K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+5K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+5K243670Idys® LIFClariance20240—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+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—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+5K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+5K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+5K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+5K230583Tryptik TiSpineart SA20231—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+5K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K210573Velofix SA Cervical CageU&I Corporation20211—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—