510(k) Report

Devices descending from K936045

3 later devices reach Ace Unilateral Fixator II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021933Tempfix External Fixation SystemDePuy Orthopaedics, Inc.20022—
+2K052918Reprocessed External Fixation DevicesAlliance Medical Corp.20060—
+2K043113Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc.20050—