510(k) Report

Devices descending from K031757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+7K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+7K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+7K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+7K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+7K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+7K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+7K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+7K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+7K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+7K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+7K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+7K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+7K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+7K120869Anchor-L Lumbar CageStryker Spine2012638—
+7K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+7K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+7K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+7K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+7K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+7K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+7K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+7K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+7K121116Plateau Spacer SystemLife Spine201213—
+7K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+7K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+7K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+7K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+7K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+7K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+7K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+7K103369Vault Alif SystemSpinal USA201110—
+7K093093Small Plateau Spacer SystemLife Spine2010393—
+7K101301Stalif MidlineCentinel Spine2010474—
+7K083475Lucent MagnumSpinal Elements, Inc.2009834—
+7K081711Lucent Magnum+Spinal Elements, Inc.20080—
+8K263049SABER-C SystemElevation Spine20260—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261430TruLift Expandable SystemLife Spine, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—