510(k) Report

Devices descending from K033901

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+1K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+1K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+1K142185Expedium Verse Spine SystemDepuy Spine, Inc.201420—
+1K133369Tiger Spine SystemCorelink, LLC201429—
+1K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+1K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+1K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+1K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+1K112484Zavation Spinal SystemZavation, LLC20115—
+1K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+1K103490Expedium Spine System, Moss Miami Spine SystemJohnson & Johnson201120—
+1K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+1K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+1K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+1K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+1K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+1K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+1K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+1K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+1K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+1K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+1K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+1K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc.2008538—
+1K073126Expedium Spine SystemDepuy Spine, Inc.2007304—
+1K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+1K071860Modification to: Viper Spine SystemDepuy Spine, Inc.2007423—
+1K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+1K071495Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company2007539—
+1K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006490—
+1K052131Expedium Spine System 5.5MM Commerically Pure Titanium Spinal RodsDepuy Spine, Inc.2005495—
+1K051024Expedium Spine SystemDepuy Spine, Inc.2005493—
+1K050675Expedium Spine System Spinous Process Fusion PlateDepuy Spine, Inc.20059—
+1K041801Expedium Mis Spine SystemDepuy Spine, Inc.2004533—
+1K041119Expedium Spine SystemDepuy Spine, Inc.2004640—
+2K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+2K243249TriALTIS™ Spine SystemMedos International SARL20250—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+2K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+2K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+2K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+2K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+2K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+2K193219G Surgical Marksman SystemG Surgical, LLC20191—
+2K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+2K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+2K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+2K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+2K182240PASS LP Spinal SystemMedicrea International SA20182—
+2K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+2K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG20162—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+2K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC20160—
+2K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+2K153404Zavation Spinal SystemZavation, LLC20161—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+2K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+2K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+2K122229Viceroy Spinal SystemTorrey Spine20120—
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+2K120469Erisma-LPClariance20126—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—