KWI · Class II · 21 CFR 888.3170

FDA Product Code KWI: Prosthesis, Elbow, Hemi-, Radial, Polymer

Leading manufacturers include Avanta Orthopaedics, Inc., Wrightmedicaltechnologyinc and Biomet, Inc..

34
Total
34
Cleared
137d
Avg days
1989
Since
34 devices
25–34 of 34
Cleared Aug 31, 2000
TORNIER BIPOLAR RADIAL HEAD PROSTHESIS
K994041
Tornier, Inc.
Orthopedic · 276d
Cleared Jul 27, 2000
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared May 11, 2000
ERS RADIAL HEAD REPLACEMENT
K000658
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared Feb 25, 2000
RADIAL HEAD PROSTHESIS
K992220
Smith & Nephew, Inc.
Orthopedic · 239d
Cleared Sep 03, 1999
MODULAR RADIAL HEAD
K991915
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Jun 01, 1999
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
K984290
Implex Corp.
Orthopedic · 182d
Cleared Sep 08, 1998
RADIAL HEAD IMPLANT
K982288
Avanta Orthopaedics, Inc.
Orthopedic · 70d
Cleared Jul 13, 1995
METALLIC RADIAL HEAD IMPLANTS
K944507
Wrightmedicaltechnologyinc
Orthopedic · 301d