510(k) Report

Devices descending from K973836

529 later devices reach Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+1K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+1K112684Mont Blanc Pedicle Screw SystemsQualgenix20125—
+1K080241DDS Stabilization SystemParadigm Spine, LLC20085—
+1K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+1K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998251—
+1K980484Aesculap Spine System EvolutionAesculap, Inc.1998251—
+1K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Cross Medical Products, Inc.1998311—
+2K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+2K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+2K151977icotec Pedicle SystemIcotec AG201630—
+2K150185Mont Blanc Spinal SystemSpineway20154—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+2K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+2K113173Nanovis Spinal SystemNanovis, LLC20122—
+2K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+2K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+2K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+2K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+2K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+2K101083DSS Stabilization SystemParadigm Spine, LLC20102—
+2K100377Diamondback Spinal SystemEminent Spine201029—
+2K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC20093—
+2K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC20094—
+2K081108Monopoly Pedicle Screw SystemSignus Medical, LLC20080—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+2K001080Spine System EvolutionAesculap, Inc.200062—
+2K993503Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc.2000176—
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999250—
+2K983353SCS Spinal SystemOrthotec, Inc.19982—
+3K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K222789VADER® Pedicle System, G21 CementIcotec AG202352
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K123717UcentumUlrich GmbH & Co. KG2013171
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+3K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K111301Instinct Java SystemZimmer Spine201131
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043