KXE · Class II · 21 CFR 888.3810

FDA Product Code KXE: Prosthesis, Wrist, Hemi-, Ulnar

Leading manufacturers include Wrightmedicaltechnologyinc, Aptis Medical, LLC and Cutter Laboratories, Inc..

16
Total
16
Cleared
114d
Avg days
1979
Since

FDA 510(k) Cleared Prosthesis, Wrist, Hemi-, Ulnar Devices (Product Code KXE)

16 devices
1–16 of 16
Cleared May 03, 2019
Aptis Medical Distal Radio Ulnar Joint Implant
K190599
Aptis Medical, LLC
Orthopedic · 56d
Cleared Feb 22, 2002
WMT MODULAR ULNAR HEAD IMPLANT
K020274
Wrightmedicaltechnologyinc
Orthopedic · 25d
Cleared Feb 08, 1979
ULNAR HEAD PROTHESIS
K790125
Cutter Laboratories, Inc.
Orthopedic · 16d

About Product Code KXE - Regulatory Context