510(k) Report

Devices descending from K980288

959 later devices reach Spine-Tech Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+6K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+6K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+6K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+6K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173508Everest Spinal SystemK2m20189—
+6K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+6K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+6K173126Arisstos™ Spinal SystemIngenium Spine20171—
+6K172469TiLock Modular Spinal SystemGenesys Spine20170—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K153404Zavation Spinal SystemZavation, LLC20161—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+6K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K151813Sniper Spine SystemSpine Wave, Inc.20159—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K150417Astra Spine SystemSpinecraft, LLC201521—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+6K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+6K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K141850Flospine Pedicle Screw SystemFlospine20140—
+6K142381Xia 3 Spinal SystemStryker Corp.201483—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+6K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+6K132757Everest Spinal SystemK2m, Inc.201341—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—