510(k) Report

Devices descending from K041888

1,586 later devices reach Curved Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K122047Alamo PAlliance Partners, LLC20120—
+5K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+5K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+5K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+5K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+5K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+5K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+5K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+5K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+5K111569Plateau Spacer SystemLife Spine2011181—
+5K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+5K110927MectalifMedacta International2011301
+5K103111Forza Spacer SystemOrthofix, Inc.20113431
+5K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+5K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+5K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+5K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+5K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+5K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+5K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+5K082801Phantom Plus Cage SystemUs Spine2008643—
+5K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+5K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+5K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+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—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+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—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K242303MOD-COrthomod, LLC20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, 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—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K250560BEE HANGMedical GmbH20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+6K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—