510(k) Report

Devices descending from K002517

662 later devices reach Uss Vas through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172206NAJA™ Ligament Correction SystemCousin Biotech Sas20182—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K162764Jazz Frame SystemImplanet, S.A.20176—
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+4K161267Response BandLoc Spinal FixationOrthoPediatrics Corp.201611
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+4K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+4K143350Nile Alternative FixationK2m, Inc.201510—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc.201423—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+4K133402K2M Modular HooksK2m, Inc.20140—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+4K132395LigapassMedicrea International201323—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K132287Jazz SystemHogan Lovells US LLP201315—
+4K124014Surefix Interspinous Fusion SystemJg Spine, LLC20130—
+4K130176Firebird Spinal Fixation SystemOrthofix20135—
+4K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+4K121541Jazz SystemImplanet, S.A.201227—
+4K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—