MBV · Class II · 21 CFR 888.3560

FDA Product Code MBV: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer

Leading manufacturers include Depuy, Inc., Richard'S Medical Equip., Inc. and Richards Medical Co., Inc..

14
Total
14
Cleared
86d
Avg days
1978
Since

FDA 510(k) Cleared Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer Devices (Product Code MBV)

14 devices
1–14 of 14
Cleared Feb 14, 2001
OFFSET TIBIAL TRAY
K010212
Biomet, Inc.
Orthopedic · 22d
Cleared Nov 21, 1989
TRICON-M TOTAL KNEE SYSTEM
K884824
Richards Medical Co., Inc.
Orthopedic · 368d
Cleared Nov 29, 1983
TRICON M TOTAL KNEE SYSTEM
K833200
Richards Medical Co., Inc.
Orthopedic · 71d
Cleared Sep 01, 1983
POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K831441
Depuy, Inc.
Orthopedic · 119d
Cleared Mar 29, 1983
RMC TOTAL KNEE SYSTEM
K823837
Richard'S Medical Equip., Inc.
Orthopedic · 98d
Cleared Feb 24, 1983
FREEMAN/SAMUELSON TOTAL KNEE
K830408
Depuy, Inc.
Orthopedic · 17d
Cleared Oct 04, 1982
TOTAL KNEE SYSTEM
K822583
Richard'S Medical Equip., Inc.
Orthopedic · 39d
Cleared Jan 08, 1981
ICLH TIBIAL PLATEAU
K802921
Depuy, Inc.
Orthopedic · 51d
Cleared Jun 22, 1978
KNEE, TOTAL, FEMORAL & TIBIAL
K780904
Depuy, Inc.
Orthopedic · 23d
Cleared Mar 15, 1978
TIBIAL PLATEU
K780284
Depuy, Inc.
Orthopedic · 22d

About Product Code MBV - Regulatory Context