510(k) Report

Devices descending from K233919

2 later devices reach VariAx 2 Distal Radius System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+2K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—