Medical device licence · 12636 · Class 3
SMARTSCREW
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed September 28, 1999; ended May 29, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 12636
- Licence holder
- Conmed Linvatec Biomaterials Ltd.Tampere, Finland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- September 28, 1999
- Ended
- May 29, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SMARTSCREW - PREVIOUS BIOFIX SR-PLLA LAG SCREWS
- SMARTSCREW - PREVIOUS BIOFIX SR-PLLA SCREW-FULLY THREADED
- SMARTSCREW II, CANNULATED, FULLY THREADED
- SMARTSCREW II, CANNULATED, PARTIALLY THREADED
- SMARTSCREW II, FULLY THREADED
- SMARTSCREW II, PARTIALLY THREADED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.