KWL · Class II · 21 CFR 888.3360

FDA Product Code KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

Leading manufacturers include Osteonics Corp., Depuy, Inc. and Biomet, Inc..

108
Total
108
Cleared
109d
Avg days
1979
Since
108 devices
97–108 of 108
Cleared Sep 20, 1983
HIP PROSTHESIS -VARIOUS
K831420
The Oec Group
Orthopedic · 140d
Cleared Mar 10, 1983
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K830307
Howmedica Corp.
Orthopedic · 38d
Cleared Dec 03, 1982
METAL KNEE & HIP PROSTHESIS
K823051
Zimmer, Inc.
Orthopedic · 46d
Cleared Aug 20, 1982
IOI 32 TM FEMORAL COMPONENT
K822321
Intermedics Orthopedics
Orthopedic · 17d
Cleared Aug 19, 1982
KAMPNER FEMORAL COMPONENT
K822320
Intermedics Orthopedics
Orthopedic · 16d
Cleared Jun 10, 1982
THE ORIGINAL LEINBACH PLATFORM TOTAL HIP
K820755
Allo Pro Corp.
Orthopedic · 83d
Cleared Jun 03, 1982
BDH FEMORAL COMPONENT
K821343
Intermedics Orthopedics
Orthopedic · 29d
Cleared Aug 12, 1981
MOORE HIP PROSTHESIS, PMMA COATED
K811416
Zimmer, Inc.
Orthopedic · 85d
Cleared Jul 20, 1981
COLLARLESS TAPERED STEM HIP PROSTH. DEV
K811738
Biomet, Inc.
Orthopedic · 31d
Cleared Jan 23, 1981
PROSTHESIS, HIP FEMORAL COMPONENT METAL
K803191
Osteonics Corp.
Orthopedic · 38d
Cleared Feb 11, 1980
UHR UNIVERSAL6HIP REPLACEMENT
K800207
Osteonics Corp.
Orthopedic · 12d
Cleared Nov 15, 1979
3M HS 22 FEMORAL COMPONENT
K792181
3M Company
Orthopedic · 17d