Medical device licence · 15039 · Class 3
OPTI-FIX HIP SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed December 2, 1999; ended October 27, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 15039
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- December 2, 1999
- Ended
- October 27, 2022
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTI-FIX HIP SYSTEM - ACETABULAR SHELL TRIAL
- OPTI-FIX HIP SYSTEM - ACETABULAR TRIAL LINER
- OPTI-FIX HIP SYSTEM - ACETABULAR TRIAL LINER ANTEVERTED
- OPTI-FIX HIP SYSTEM - ANTEVERTED XLPE ACETABULAR LINER
- OPTI-FIX HIP SYSTEM - LOW PROFILE OPTI-FIX CANCELLOUS SCREWS
- OPTI-FIX HIP SYSTEM - OPTI-FIX CANCELLOUS SCREWS
- OPTI-FIX HIP SYSTEM - OPTI-FIX COLLARED FEMORAL STEM
- OPTI-FIX HIP SYSTEM - OPTI-FIX CORTICAL SCREW
- OPTI-FIX HIP SYSTEM - OPTI-FIX FEMORAL COMPONENT
- OPTI-FIX HIP SYSTEM - OPTI-FIX II SHELL
- OPTI-FIX HIP SYSTEM - OPTI-FIX LINER
- OPTI-FIX HIP SYSTEM - OPTI-FIX REVISION COLLARED STEM
- OPTI-FIX HIP SYSTEM - OPTI-FIX SHELL
- OPTI-FIX HIP SYSTEM - OPTI-FIX XLPE LINER
- OPTI-FIX II FEMORAL COMPONENT
- OPTI-FIX PLUS FEMORAL COMPONENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.