HSD · Class II · 21 CFR 888.3690

FDA Product Code HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Leading manufacturers include Howmedica Osteonics Corp., Arthrex, Inc. and Biomet, Inc..

71
Total
71
Cleared
120d
Avg days
1979
Since
71 devices
25–48 of 71
Cleared Jul 12, 1996
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
K954559
Howmedica Corp.
Orthopedic · 284d
Cleared May 30, 1995
INFINITY SHOULDER SYSTEM
K943908
Wrightmedicaltechnologyinc
Orthopedic · 292d
Cleared Jul 15, 1991
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
K911686
Depuy, Inc.
Orthopedic · 90d
Cleared Sep 16, 1980
MONOSPHERICAL SHOULDER PROSTHESIS
K802123
Howmedica Corp.
Orthopedic · 12d
Cleared Mar 18, 1980
NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS
K800494
Depuy, Inc.
Orthopedic · 14d