510(k) Report

Devices descending from K000319

700 later devices reach Ebi Xfix DFS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K212700Dyflex-IITaeyeon Medical Co., Ltd.20220—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+4K2024984CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited20213—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203452Nano FortiFix® SystemNanovis, LLC20200—
+4K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+4K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+4K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K181824CBT Screw Fixation SystemU&I Corporation20180—
+4K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+4K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+4K180324Patriot Spinal Fixation SystemValorus Spine20180—
+4K173524ANAX 5.5™ Spinal SystemU&I Corporation201721
+4K173126Arisstos™ Spinal SystemIngenium Spine20171—
+4K172546AnyPlus® Spinal Fixation SystemGS Medical Co., Ltd.201712—
+4K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+4K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K162189ANAX™ 5.5 Spinal SystemU&I Corporation20163—
+4K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+4K153152Syzygy Stabilization SystemAmendia, Inc.201602
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K143110GALAXY MIS Screw SystemBm Korea20152—
+4K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+4K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+4K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+4K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K130655Response Spine SystemOrthoPediatrics Corp.201317—
+4K123717UcentumUlrich GmbH & Co. KG2013171
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+4K122931S-Lok PSS SystemSpinal USA20120—
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+4K121568Dali Spinal Fixation SystemAccel Spine20121—
+4K121630Range Spinal SystemK2m, Inc.2012127—
+4K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+4K121172Reform Pedicle Screw SystemSpinal USA201233—
+4K120760LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc.20124—
+4K121250OP Spine SystemOrthoPediatrics Corp.201218—
+4K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+4K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+4K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+4K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+4K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+4K102574Palla M Spinal SystemKorea Bone Bank Co., Ltd.20112—
+4K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology201090—
+4K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology20108—
+4K100765Fixpine II SystemDio Medical Co., Ltd.201023—
+4K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+4K100575LDR Spine Usa Spine Tune TL Spine SystemLdr Spine USA20107—
+4K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+4K091717Any Plus Spinal Fixation SystemGS Medical Co., Ltd.2010130—
+4K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+4K092128Modification to: PSS SystemSpinal USA200936—
+4K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+4K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+4K090033Modification to: PSS SystemSpinal USA200937—
+4K082509Eos Spinal SystemKorea Bone Bank Co., Ltd.2008140—
+4K0824534CIS Solar and Apollon Spine SystemsSolco Biomedical Co., Ltd.2008126—
+4K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—