JDL · Class III · 21 CFR 888.3320

FDA Product Code JDL: Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

Leading manufacturers include Wrightmedicaltechnologyinc, Howmedica Corp. and Osteonics Corp..

45
Total
45
Cleared
153d
Avg days
1977
Since
45 devices
25–45 of 45
Cleared Nov 17, 1989
POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
K895607
Exactech, Inc.
Orthopedic · 60d
Cleared Oct 11, 1989
PNEUMOTHORAX KIT, MOTIFICATION
K892640
Arrow Intl., Inc.
Orthopedic · 182d
Cleared May 08, 1987
KM-4(TM) METAL-BACKED ACETABULAR CUP
K870867
Kirschner Medical Corp.
Orthopedic · 66d
Cleared Mar 14, 1986
KM-3 ACETABULAR COMPONENT
K855042
Kirschner Medical Corp.
Orthopedic · 87d
Cleared Mar 10, 1986
DIMENSION TOTAL HIP PROSTHESIS POROUS COATED
K854107
Kirschner Medical Corp.
Orthopedic · 153d
Cleared Mar 05, 1986
LINK METAL-BACKED ACETABULAR CUPS
K854935
Link America, Inc.
Orthopedic · 85d
Cleared Jun 18, 1985
LIDGRER-LUND ACETABULAR SOCKETS
K852369
Link America, Inc.
Orthopedic · 14d
Cleared May 09, 1985
MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA
K850793
Intermedics Orthopedics
Orthopedic · 72d
Cleared Apr 25, 1985
MICRO-STRUC. ACETABULAR COMPON- MC2P
K850352
Osteonics Corp.
Orthopedic · 87d
Cleared Feb 19, 1985
MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT
K844482
Advanced Biosearch Assn.
Orthopedic · 92d
Cleared Nov 08, 1984
DORR HIP PROSTHESIS, ACETABULAR COMPON
K842893
Carbomedics, Inc.
Orthopedic · 108d
Cleared Apr 11, 1983
NATURAL LOCK ACETABULAR COMPONENT
K830662
Advanced Biosearch Assn.
Orthopedic · 39d
Cleared Jan 22, 1982
101-32 FEMORAL COMPONENT
K813599
Intermedics Orthopedics
Orthopedic · 25d
Cleared Mar 26, 1979
BG PROXIMAL FEMUR
K790274
Howmedica Corp.
Orthopedic · 46d
Cleared Mar 17, 1977
PROSTHESIS, VIDAL TOTAL HIP
K770472
Howmedica Corp.
Orthopedic · 7d