510(k) Report

Devices descending from K022949

867 later devices reach Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+4K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+4K172206NAJA™ Ligament Correction SystemCousin Biotech Sas20182—
+4K180324Patriot Spinal Fixation SystemValorus Spine20180—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+4K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+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—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161267Response BandLoc Spinal FixationOrthoPediatrics Corp.201611
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+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
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+4K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+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—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+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—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142699LITe Plate SystemStryker Corporation201446—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+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—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K133482Silc Fixation SystemGlobus Medical, Inc.201411—
+4K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+4K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+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—
+4K123717UcentumUlrich GmbH & Co. KG2013171
+4K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+4K121541Jazz SystemImplanet, S.A.201227—
+4K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+4K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+4K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc.2011242—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+4K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+4K092610Modification to Beacon Stabilization SystemGlobus Medical, Inc.2009375—