510(k) Report

Devices descending from K024364

1,683 later devices reach Synthes Vertebral Spacer TI (Curved and Narrow) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+7K131547Lanx Fusion SystemLanx, Inc.20131631
+7K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+7K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+7K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+7K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+7K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+7K122047Alamo PAlliance Partners, LLC20120—
+7K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+7K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+7K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+7K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+7K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+7K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+7K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+7K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+7K111569Plateau Spacer SystemLife Spine2011181—
+7K110927MectalifMedacta International2011301
+7K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+7K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+7K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+7K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+7K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+7K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+7K082801Phantom Plus Cage SystemUs Spine2008643—
+7K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+7K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+7K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+8K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261430TruLift Expandable SystemLife Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+8K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+8K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K234150Lucent® XPSpinal Elements20240—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+8K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+8K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+8K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+8K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—