510(k) Report

Devices descending from K962628

905 later devices reach Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+4K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+4K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K151216Everest Spinal SystemK2m, Inc.201511—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K142699LITe Plate SystemStryker Corporation201446—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K123717UcentumUlrich GmbH & Co. KG2013171
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+4K121568Dali Spinal Fixation SystemAccel Spine20121—
+4K113666Xia 3 Spinal SystemStryker Spine2012251—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+4K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+4K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+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—
+4K092631Mantis Redux Spinal SystemStryker Spine2009110—
+4K092610Modification to Beacon Stabilization SystemGlobus Medical, Inc.2009375—
+4K090320Conquest Spinal SystemLife Spine20092—
+4K083393Xia 3 Spinal SystemStryker Spine20092921
+4K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+4K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+4K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+4K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+4K072605Malibu Spinal SystemSeaspine, Inc.200767—
+4K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+4K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+4K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+4K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—