510(k) Report

Devices descending from K033826

135 later devices reach Orthopedic Alliance Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110633Lancer Pedicle Screw SystemSpinal Solutions, LLC201108
+1K043484Lanx Spinal Fixation SystemLanx, LLC200577—
+1K043094Easyspine SystemLdr Spine USA200555—
+2K121924Integra Interspinous Process SystemSeaspine, Inc.20131—
+2K123134Easyspine SystemLdr Spine USA, Inc.20131—
+2K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+2K121940Lanx Spinal Fixation SystemLanx, Inc.20128—
+2K103237Lanx Spinal SystemLanx, Inc.201118—
+2K090252Modification to: Lanx Spinal Fixation SystemLanx, Inc.200918—
+2K082592LDR Spine Easyspine SystemLdr Spine USA200820—
+2K071877Lanx Spinal Fixation SystemLanx, LLC200775—
+2K071633Lanx Deformity SystemLanx, LLC200729—
+2K070341LDR Spine Easyspine Posterior Osteosynthesis SystemLdr Spine USA200717—
+2K063794Modification to Easyspine SystemLdr Spine USA200717—
+2K061017Easyspine SystemLdr Spine USA200650—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation20180—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K153302coflex-IFParadigm Spine, LLC20162—
+3K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+3K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+3K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+3K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+3K140236Aileron Interspinous Fixation SystemLife Spine, Inc.20140—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+3K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133091Zip Mis Interspinous Fusion SystemAurora Spine201314—
+3K130066Spectrum Spine Spinous Process DeviceSpectrum Spine IP Holdings, LLC20130—
+3K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+3K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC20126—
+3K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+3K113157Aileron Interspinous Fixation SystemLife Spine20121—
+3K120399Lanx Spinal Fixation SystemLanx, LLC201217—
+3K102886CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20112—
+3K102195SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc.201132—
+3K093438Paradigm Interspinous Fusion PlateParadigm Spine, LLC201051
+3K102020Vega Span Spinous Process Plate SystemSpinefrontier, Inc.20108—
+3K100354Primal OK Interspinous Fusion SystemOsteomed LP201037—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+4K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.20230—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+4K221399ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc.20220—
+4K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+4K213266Inspan ScrewLES Fusion SystemLespine Innovations, LLC20213—
+4K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+4K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+4K201704CoFix SystemParadigm Spine GmbH20200—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K161016Z-Clamp ISP SystemZavation, LLC20160—
+4K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+4K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+4K141317Zip Mis Interspinous Fusion SystemAurora Spine, Inc.20142—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K140715Zip Mis Interspinous Fusion SystemAurora Spine, Inc.20143—
+4K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc.20145—
+4K132191SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc.20136—
+4K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+4K131238Affix Spinous Process Plate SystemNuvasive, Inc.201330—
+4K123232Spineology Spinous Process PlateSpineology, Inc.20131—
+4K121316Lanx Spinal Fization SystemLanx, Inc.20123—
+4K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+4K112595Coflex-FParadigm Spine, LLC20124—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K171321K2M Navigation InstrumentsK2m201711