510(k) Report

Devices descending from K200430

3 later devices reach Precice® Ankle Salvage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc.20231—
+1K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+2K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics20260—