510(k) Report

Devices descending from K001358

4 later devices reach Ebi Xfix DFS Metaphyseal Correction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+1K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma200821
+2K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V20130—
+2K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC)20110—