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
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+7K240442MagnetOs PuttyKuros Biosciences B.V20243—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K240715Idys® C ZP 3DTiClariance20240—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+7K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—
+7K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+7K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+7K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232315Catalyst Bone Void FillerOssdsign AB20237—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+7K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+7K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K212930LumiVy Lumbar IBF SystemVy Spine, LLC20226—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+7K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+7K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+7K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+7K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+7K182721Choice Spine Navigation SystemChoicespine, LP20192—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+7K180437Hexanium® TLIFSpinevision, S.A.S.20182—