JDK · Class II · 21 CFR 878.3300

FDA Product Code JDK: Prosthesis, Hip, Cement Restrictor

Leading manufacturers include Osteonics Corp., Medtronic Sofamor Danek, Inc. and Spinal Concepts, Inc..

54
Total
54
Cleared
106d
Avg days
1983
Since
54 devices
49–54 of 54
Cleared Nov 22, 1989
PROXIMAL CEMENT SPACER
K895378
Osteonics Reconstructive Products Div.
Orthopedic · 84d
Cleared Oct 10, 1989
PT DISTAL TIP CEMENT SPACER
K894708
Osteonics Corp.
Orthopedic · 78d
Cleared Dec 29, 1987
OMNIFIT DISTAL STEM CEMENT SPACERS
K872528
Osteonics Corp.
Orthopedic · 187d
Cleared Mar 05, 1984
CEMENT RESTRICTOR
K840413
American Ortomed Corp.
Orthopedic · 34d
Cleared Sep 29, 1983
DOSIMETRY RELEASE OF RADIATION STERILIZ
K831512
Biomet, Inc.
Orthopedic · 140d
Cleared Jul 12, 1983
BARD INTRAMEDULLARY PLUG
K831128
C.R. Bard, Inc.
Orthopedic · 97d