KWA · Class III · 21 CFR 888.3330

FDA Product Code KWA: Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

Leading manufacturers include Wrightmedicaltechnologyinc, Biomet Manufacturing Corp and DePuy Orthopaedics, Inc..

114
Total
114
Cleared
119d
Avg days
1978
Since
114 devices
97–114 of 114
Cleared Jun 18, 1985
OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES
K851404
Osteonics Corp.
Orthopedic · 70d
Cleared Jun 03, 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843940
Waldemar Link GmbH & Co. KG
Orthopedic · 237d
Cleared Jun 03, 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843950
Waldemar Link GmbH & Co. KG
Orthopedic · 237d
Cleared May 02, 1985
PM CEMENTLESS SCREW-IN ACETABULAR CUP
K850773
Advanced Biosearch Assn.
Orthopedic · 66d
Cleared May 01, 1985
ZIMMER THREADED ACETABULAR CUP
K850766
Zimmer, Inc.
Orthopedic · 65d
Cleared Apr 23, 1985
PROFILE FEMORAL HIP
K850055
Depuy, Inc.
Orthopedic · 105d
Cleared Mar 18, 1985
WEILL CEMENTLESS THREADED ACETABULAR CUP
K844943
Advanced Biosearch Assn.
Orthopedic · 88d
Cleared May 12, 1978
TOTAL HIP, LORD MADREPORIC
K780330
Howmedica Corp.
Orthopedic · 73d