510(k) Report

Devices descending from K061202

547 later devices reach Revere Stabilization System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+3K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+3K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+3K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K162143FixxSure® X-LinkInnovasis, Inc.20160—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+3K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+3K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K150449LITe Plate SystemStryker Corp.201524—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—