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
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+7K182721Choice Spine Navigation SystemChoicespine, LP20192—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K181397DualXInnovasive, Inc.201815—
+7K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+7K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+7K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+7K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+7K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+7K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+7K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+7K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+7K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+7K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+7K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+7K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+7K143479Bluefin Interbody SystemTides Medical20152—
+7K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+7K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+7K141135Juliet LLSpineart2014146—
+7K141896Coroent SystemNu Vasive, Incorporated2014480—
+7K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+7K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K140529Everest Spinal SystemK2m, LLC201431—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+7K132757Everest Spinal SystemK2m, Inc.201341—
+7K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K130445Vault Alif SystemSpinal USA20139—
+7K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+7K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+7K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+7K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+7K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+8K263049SABER-C SystemElevation Spine20260—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260660SABER-C SystemElevation Spine20261—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K250540SABER-C SystemElevation Spine20252—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—