510(k) Report

Devices descending from K022143

968 later devices reach Interpore Cross International Anterior Fixation Device (Afd) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181397DualXInnovasive, Inc.201815—
+6K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+6K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+6K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+6K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+6K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+6K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K151654Prow FusionNlt Spine, Ltd.20151—
+6K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+6K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+6K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K250540SABER-C SystemElevation Spine20252—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402