Medical device licence · 66834 · Class 3
UNIVERSAL DISTAL RADIUS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 13, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 66834
- Licence holder
- Stryker GmbhSelzach, SO, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 13, 2004
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- UNIVERSAL DISTAL RADIUS SYSTEM - MARKER BONE SCREWS
- UNIVERSAL DISTAL RADIUS SYSTEM - MARKER LOCKING SCREWS
- UNIVERSAL DISTAL RADIUS SYSTEM - MARKER PARTIALLY THREADED BONE SCREWS
- UNIVERSAL DISTAL RADIUS SYSTEM - SMARTLOCK COLUMN PLATES.
- UNIVERSAL DISTAL RADIUS SYSTEM - SMARTLOCK LOCKING PLATES (TITANIUM)
- UNIVERSAL DISTAL RADIUS SYSTEM - TITANIUM BONE SCREWS
- UNIVERSAL DISTAL RADIUS SYSTEM - TITANIUM LOCKING PEGS
- UNIVERSAL DISTAL RADIUS SYSTEM - TITANIUM LOCKING SCREWS
- UNIVERSAL DISTAL RADIUS SYSTEM - TITANIUM PARTIALLY THREADED BONE SCREWS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.