510(k) Report

Devices descending from K021031

8 later devices reach Ebi Xfix Rail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V20130—
+1K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma200821
+1K031875Inter-OS Limb LengthenerInter-Os Technologies20034—
+2K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+2K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC)20110—
+2K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+3K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+3K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—