Medical device licence · 11077 · Class 3
P.F.C TOTAL HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 8, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11077
- Licence holder
- Depuy Orthopaedics, Inc.Warsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 8, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- P.F.C TOTAL HIP SYSTEM - ACETABULAR LINER
- P.F.C TOTAL HIP SYSTEM - ACETABULAR SHELLS CEMENTED
- P.F.C TOTAL HIP SYSTEM - ACETABULAR SHELLS POROUS
- P.F.C TOTAL HIP SYSTEM - FEMORAL HEADS
- P.F.C TOTAL HIP SYSTEM - LX CEMENTED STEM
- P.F.C TOTAL HIP SYSTEM - PFC 2 POROUS COATED FEMORAL COMPONENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.