Medical device licence · 2398 · Class 3
P.F.C. TOTAL KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 20, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 2398
- Licence holder
- Depuy Orthopaedics, Inc.Warsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 20, 1999
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PFC TOTAL KNEE SYSTEM CURVED INSERTS
- PFC TOTAL KNEE SYSTEM FERMORAL COMPONENT NON POROUS
- PFC TOTAL KNEE SYSTEM KEEL TRAY NB
- PFC TOTAL KNEE SYSTEM P/L INSERTS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.