510(k) Report

Devices descending from K000319

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma200821
+1K021695Ebi Dynafix Diaphyseal Correction SystemEbi, L.P.20025—
+1K020279Forex Corporation, Optima, Spinal SystemForex Corp.20026934
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+2K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+2K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V20130—
+2K111376Construx External Fixation DeviceEbi, LLC201101
+2K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC)20110—
+2K093104Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd.201020—
+2K071879Zimmer Dto ImplantZimmer Spine, Inc.200711
+2K071857Delta Spinal Fusion SystemJemo Spine, LLC2007109—
+2K070933Lowtop Pedicle Screw SystemSanacor2007178—
+2K031585U&I, Optima, Spinal SystemU&I Corp., America20035795
+2K024096Optima, Spinal SystemU&I Corp., America20034663
+2K030372Modification to Ebi Dynafix Diaphyseal Correction SystemEbi, L.P.20033—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+3K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+3K143417ANAX 5.5 Spinal SystemU&I Corporation20154—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+3K132218Perfix Iliac Screw SystemU&I Corporation20130—
+3K130073Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal RodsMikron Makina Sanayi VE Ticaret Ltd. Sti.20135—
+3K132101Anax 5.5 Spinal SystemU&I Corporation201313—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+3K1216154CIS Vane Spine SystemSolco Biomedical Co., Ltd.20121—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+3K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+3K113361Securis Spinal FixationCumtom Spine20120—
+3K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+3K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+3K111995Xingtm Spine SystemImplanova Co., Ltd.20110—
+3K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+3K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+3K1024584CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd.20114—
+3K110283Zenius Spinal SystemMedyssey Co, Ltd.201114—
+3K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+3K1018184CIS Vane Spine SystemSolco Biomedical Co., Ltd.20112—
+3K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123—
+3K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+3K103272Zenius Spinal SystemMedyssey Co, Ltd.201015—
+3K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+3K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+3K102331LDR Spine Usa Spinetune TL Spinal SystemLdr Spine USA20106—
+3K101704Zimmer Dto Pin Press InstrumentZimmer Spine, Inc.20100—
+3K100706Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2010124—
+3K100956Spondy Spinal Fixation SystemAllure Spine LLC201017—
+3K100373Tyche Pedicle Screw SystemKyung Won Medical Co., Ltd.20104—
+3K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+3K091725Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)U&I Corp.2009150—
+3K092011Norm Spinal SystemNorm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar20090—
+3K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd.20090—
+3K081145Modification to 4CIS Vane Spine SystemSolco Biomedical Co., Ltd.2008127—
+3K081108Monopoly Pedicle Screw SystemSignus Medical, LLC20080—
+3K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+3K080504Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology200892—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+3K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+3K072436Mega Spine SystemBk Meditech, Co., Ltd.20079—
+3K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology2007177—
+3K071438PSS SystemSpinal USA200739—
+3K0637084S Spinal SystemTaeyeon Medical Co., Ltd.20078—
+3K062785LTD Polyaxial Fixation SystemUs Spine200641—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K051704Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20066—
+3K0607024CIS Vane Spine SystemSolco Biomedical Co., Ltd.2006166—
+3K053573GSS Pedicle Screw SystemGS Medical Co., Ltd.2006181—
+3K053070Contour II Spinal SystemAltiva Corp.20060—
+3K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+3K0504714CIS Solar Spine System and 4CIS Apollon Spine SystemSolco Biomedical Co., Ltd.2005127—
+3K043578The 4CIS Spinal System and 4CIS Low Back SystemSolco Biomedical Co., Ltd.2005125—
+3K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+3K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc.20041801
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—