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FDA Product Code

FDA Product Code MBV — Clearance Directory

Device Class
Class II
Assigned Panel
Orthopedic
21 CFR Citation
888.3560

510(k) Clearances — 14 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K010212 OFFSET TIBIAL TRAY Biomet, Inc. 2001-02-14 Special PDF ↗
K884824 TRICON-M TOTAL KNEE SYSTEM Richards Medical Co., Inc. 1989-11-21 Traditional PDF ↗
K873429 FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE Protek, Inc. 1987-10-28 Traditional PDF ↗
K853730 FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP Protek, Inc. 1986-02-18 Traditional PDF ↗
K833200 TRICON M TOTAL KNEE SYSTEM Richards Medical Co., Inc. 1983-11-29 Traditional PDF ↗
K831441 POROCOAT FREEMAN/SAMUELSON TOTAL KNEE Depuy, Inc. 1983-09-01 Traditional PDF ↗
K832302 MARK I TOTAL KNEE SYS. ARTHROPLASTY Advanced Biosearch Assn. 1983-08-16 Traditional PDF ↗
K830726 MARK I & II TOTAL KNEE REPLACE. SYS Advanced Biosearch Assn. 1983-06-22 Traditional PDF ↗
K823837 RMC TOTAL KNEE SYSTEM Richard'S Medical Equip., Inc. 1983-03-29 Traditional PDF ↗
K830408 FREEMAN/SAMUELSON TOTAL KNEE Depuy, Inc. 1983-02-24 Traditional PDF ↗
K822583 TOTAL KNEE SYSTEM Richard'S Medical Equip., Inc. 1982-10-04 Traditional PDF ↗
K802921 ICLH TIBIAL PLATEAU Depuy, Inc. 1981-01-08 Traditional PDF ↗
K780904 KNEE, TOTAL, FEMORAL & TIBIAL Depuy, Inc. 1978-06-22 Traditional PDF ↗
K780284 TIBIAL PLATEU Depuy, Inc. 1978-03-15 Traditional PDF ↗

Product code MBV · Class II · Orthopedic. Data: openFDA.