510(k) Report

Devices descending from K081832

4 later devices reach Ensplintcmx Clavicle Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC20171—
+1K111550Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy (X=Dia…Sonoma Orthopedic Products, Inc.20110—
+1K100112Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM)Sonoma Orthopedic Products, Inc.20102—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—