510(k) Report

Devices descending from K112218

2 later devices reach Ace-Fischer (R), Tempfix (R), Hoffman Classic (TM) External Fixators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+2K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—