510(k) Report

Devices descending from K003709

1,714 later devices reach Surgical Dynamics Mesh Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+6K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+6K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+6K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+6K130461Stalif XCentinel Spine, Inc.201313—
+6K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+6K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+6K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+6K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+6K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+6K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+6K123231Caliber SpacersGlobus Medical, Inc.2013657—
+6K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+6K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+6K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+6K120869Anchor-L Lumbar CageStryker Spine2012638—
+6K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+6K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+6K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+6K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+6K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+6K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+6K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+6K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+6K121116Plateau Spacer SystemLife Spine201213—
+6K120656Everest Spinal SystemK2m, Inc.201243—
+6K120101Independence SpacerGlobus Medical, Inc.2012224—
+6K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+6K113447Rise SpacerGlobus Medical, Inc.2012691—
+6K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+6K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+6K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+6K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+6K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+6K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+6K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+6K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+6K103369Vault Alif SystemSpinal USA201110—
+6K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+6K101301Stalif MidlineCentinel Spine2010474—
+6K083475Lucent MagnumSpinal Elements, Inc.2009834—
+6K081711Lucent Magnum+Spinal Elements, Inc.20080—
+7K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+7K263049SABER-C SystemElevation Spine20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+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—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+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—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—