510(k) Report

Devices descending from K082572

659 later devices reach Uss Iliosacral, Uss Polyaxial through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+4K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+4K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+4K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+4K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+4K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+4K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K171321K2M Navigation InstrumentsK2m201711
+4K172194Connector SystemOrthofix, Inc.2017162
+4K171881JAZZ Passer BandImplanet, S.A.20170—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+4K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161016Z-Clamp ISP SystemZavation, LLC20160—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K160698LigaPASSMedicrea International SA201612—