510(k) Report

Devices descending from K961433

8 later devices reach Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma200821
+1K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc.20060—
+1K043113Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc.20050—
+1K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc.20022—
+2K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V20130—
+2K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC)20110—
+2K022688Versabond AB Bone CementSmith & Nephew, Inc.200401
+2K022676Orthoguard AB Antimicrobial SleeveSmith & Nephew, Inc.20020—