KXE · Class II · 21 CFR 888.3810

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

Leading manufacturers include Aptis Medical, LLC, Avanta Orthopaedics, Inc. and Wrightmedicaltechnologyinc.

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 Apr 03, 2015
Aptis Medical Distal Radio Ulnar Joint Implant
K142569
Aptis Medical, LLC
Orthopedic · 203d
Cleared Apr 09, 2012
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
K112481
Ascension Orthopedic
Orthopedic · 224d
Cleared Jul 19, 2006
SBI ULNAR HEAD IMPLANT
K061146
Small Bone Innovations, Inc.
Orthopedic · 85d
Cleared Dec 07, 2005
DISTAL RADIO-ULNAR JOINT IMPLANT
K053119
Aptis Medical, LLC
Orthopedic · 30d
Cleared Nov 03, 2005
ASCENSION MUH
K052137
Ascension Orthopedics, Inc.
Orthopedic · 90d
Cleared Dec 27, 2004
HERBERT ULNAR HEAD PROSTHESIS SYSTEM
K042902
Stuckenbrock Medizintechnik GmbH
Orthopedic · 68d
Cleared Feb 22, 2002
WMT MODULAR ULNAR HEAD IMPLANT
K020274
Wrightmedicaltechnologyinc
Orthopedic · 25d
Cleared Apr 11, 2001
ULNAR HEAD IMPLANT
K010786
Avanta Orthopaedics, Inc.
Orthopedic · 27d
Cleared Dec 04, 1998
ULNAR HEAD IMPLANT
K982268
Avanta Orthopaedics, Inc.
Orthopedic · 158d
Cleared Aug 18, 1981
SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
K812053
Dow Corning Corp. Healthcare Industries Materials
Orthopedic · 28d
Cleared Feb 08, 1979
ULNAR HEAD PROTHESIS
K790125
Cutter Laboratories, Inc.
Orthopedic · 16d

About Product Code KXE - Regulatory Context