510(k) Report

Devices descending from K062196

559 later devices reach SFX Snap-Fit Cross Connector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+1K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+1K090799Modification to Expedium Spine SystemDepuy Spine, Inc.20094—
+1K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc.2008538—
+1K071495Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company2007539—
+1K070300Expedium SFX Cross Connector SystemDepuy Spine, Inc.2007311
+2K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+2K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+2K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+2K130877Expedium Spine SystemMedos International SARL20138—
+2K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+2K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+2K101070Expedium Spine SystemMedos International SARL20102601
+2K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+2K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+2K081153Novel Spinal SystemMedyssey Co, Ltd.200923—
+2K083743Capsure PS SystemSpine Wave, Inc.20093—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+2K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+2K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+2K081252Expedium 4.5MM Spine SystemDepuy Spine, Inc.200844—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+3K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173508Everest Spinal SystemK2m20189—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+3K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K133103Aversion Pedicle Screw SystemK7, LLC20140—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+3K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+3K121020Viper SystemDepuy Spine, Inc.201294—
+3K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+3K113044Synthes MirsSynthes Spine2011933
+3K110551Expedium Spine SystemJohnson & Johnson20111—
+3K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K110284Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201112—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K103147Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201013—
+3K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+3K100757Tilock Pedicle Screw SystemGenesys Spine201091
+3K093104Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd.201020—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+3K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—