510(k) Report

Devices descending from K051205

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+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—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243188Cylox® STSignus Medizintechnik GmbH20250—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+9K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+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—
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+9K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+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
+9K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+9K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+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—
+9K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+9K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+9K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+9K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+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—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252322SIros-X SystemGenesys Spine20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+10K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+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—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+10K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—