JDC · Class II · 21 CFR 888.3150

FDA Product Code JDC: Prosthesis, Elbow, Constrained, Cemented

Leading manufacturers include Zimmer, Inc., Biomet, Inc. and DePuy Orthopaedics, Inc..

29
Total
29
Cleared
105d
Avg days
1986
Since
29 devices
25–29 of 29
Cleared Oct 09, 1990
PNEUMOTHORAX KIT, MODIFICATION
K904021
Arrow Intl., Inc.
Orthopedic · 41d
Cleared Feb 03, 1989
COONRAD III TOTAL ELBOW
K883665
Zimmer, Inc.
Orthopedic · 161d
Cleared Jun 25, 1987
POROCOAT MARK II TOTAL ELBOW
K872084
Depuy, Inc.
Orthopedic · 27d
Cleared Jun 27, 1986
OSTEONICS ELBOW PROSTHESIS
K861680
Osteonics Corp.
Orthopedic · 57d