510(k) Report

Devices descending from K140463

3 later devices reach Integra External Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+1K160830Integra External Fixation SystemAscension Orthopedics201602
+2K233025Revolution External Plating SystemNew Standard Device Dba Metalogix20240—