FDA Product Code KXE: Prosthesis, Wrist, Hemi-, Ulnar
Leading manufacturers include Aptis Medical, LLC, Avanta Orthopaedics, Inc. and Ascension Orthopedic.
16
Total
16
Cleared
114d
Avg days
1979
Since
FDA 510(k) Cleared Prosthesis, Wrist, Hemi-, Ulnar Devices (Product Code KXE)
16 devices
Cleared
May 03, 2019
Aptis Medical Distal Radio Ulnar Joint Implant
Aptis Medical, LLC
Orthopedic
56d
Cleared
Apr 03, 2015
Aptis Medical Distal Radio Ulnar Joint Implant
Aptis Medical, LLC
Orthopedic
203d
Cleared
Apr 09, 2012
FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
Ascension Orthopedic
Orthopedic
224d
Cleared
Nov 21, 2008
ISOELASTICU
Remi Sciences, Inc.
Orthopedic
225d
Cleared
Oct 24, 2008
DISTAL RADIO-ULNAR JOINT IMPLANT
Aptis Medical, LLC
Orthopedic
28d
Cleared
Jul 19, 2006
SBI ULNAR HEAD IMPLANT
Small Bone Innovations, Inc.
Orthopedic
85d
Cleared
Dec 07, 2005
DISTAL RADIO-ULNAR JOINT IMPLANT
Aptis Medical, LLC
Orthopedic
30d
Cleared
Nov 03, 2005
ASCENSION MUH
Ascension Orthopedics, Inc.
Orthopedic
90d
Cleared
Jan 26, 2005
DISTAL RADIO-ULNAR JOINT IMPLANT
Aptis Medical, LLC
Orthopedic
335d
Cleared
Dec 27, 2004
HERBERT ULNAR HEAD PROSTHESIS SYSTEM
Stuckenbrock Medizintechnik GmbH
Orthopedic
68d
Cleared
Jul 28, 2004
KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
Kapp Surgical Instrument, Inc.
Orthopedic
223d
Cleared
Feb 22, 2002
WMT MODULAR ULNAR HEAD IMPLANT
Wrightmedicaltechnologyinc
Orthopedic
25d
Cleared
Apr 11, 2001
ULNAR HEAD IMPLANT
Avanta Orthopaedics, Inc.
Orthopedic
27d
Cleared
Dec 04, 1998
ULNAR HEAD IMPLANT
Avanta Orthopaedics, Inc.
Orthopedic
158d
Cleared
Aug 18, 1981
SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
Dow Corning Corp. Healthcare Industries Materials
Orthopedic
28d
Cleared
Feb 08, 1979
ULNAR HEAD PROTHESIS
Cutter Laboratories, Inc.
Orthopedic
16d