Medical device licence · 61864 · Class 3
P.C.A. KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 21, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 61864
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 21, 2003
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- P.C.A. KNEE SYSTEM - ALL POLY PATELLA
- P.C.A. KNEE SYSTEM - MTK REVISION TIBIAL INSERTS
- P.C.A. KNEE SYSTEM - P/R TIBIAL INSERTS
- PCA MOD TOTAL KNEE REVISION TIBIAL INSERT TRIAL
- PCA TOTAL KNEE SYSTEM- REVISION TIBIAL INSERTS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.