510(k) Report

Devices descending from K033901

737 later devices reach Merlin Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+3K173508Everest Spinal SystemK2m20189—
+3K172469TiLock Modular Spinal SystemGenesys Spine20170—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171582NEO Pedicle Screw System™Neo Medical SA20170—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+3K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153326Erisma-LP Spinal Fixation SystemClariance, Sas201651
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K151813Sniper Spine SystemSpine Wave, Inc.20159—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K143350Nile Alternative FixationK2m, Inc.201510—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+3K131343Reform Pedicle Screw SystemSpinal USA201331—
+3K130279Reform Pedicle Screw SystemSpinal USA201331—
+3K131030Range Spinal SystemK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+3K123717UcentumUlrich GmbH & Co. KG2013171
+3K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K121728Tiger Spine SystemCorelink, LLC201250—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121316Lanx Spinal Fization SystemLanx, Inc.20123—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+3K121172Reform Pedicle Screw SystemSpinal USA201233—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+3K120899Range Spinal System, Unit RodK2m, Inc.201235—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+3K120656Everest Spinal SystemK2m, Inc.201243—
+3K120696Tiger Spine SystemCorelink, LLC201241—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+3K112037Range Spinal System (Mesa and Denali)K2m, Inc.201165—
+3K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+3K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+3K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K080767Conquest Spinal SystemLife Spine200821—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+3K061813Mantis Spinal SystemStryker Spine20061352
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252322SIros-X SystemGenesys Spine20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—