510(k) Report

Devices descending from K042571

894 later devices reach Stryker Spine Avs TL Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K241525ExcelsiusXR™Globus Medical, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+9K211740DualXAmplify Surgical, Inc.20211—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+9K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+9K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+9K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+9K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+9K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+9K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+9K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+9K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+9K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+9K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+9K171425Concorde LiftMedos International SARL201782
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K252322SIros-X SystemGenesys Spine20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+10K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+10K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+10K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+10K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+10K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+10K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+10K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+10K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+10K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+10K182349Concorde LiftMedos International SARL20190—
+10K173537Concorde Lift™Medos International SARL20181—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+11K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+11K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+11K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+11K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+12K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—