Medical device licence · 96189 · Class 3
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 7, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 96189
- Licence holder
- Zimmer Inc.Winterthur, SZ, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 7, 2015
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- XTRAFIX SMALL EXTERNAL FIXATION SYSTEM- BAR
- XTRAFIX SMALL EXTERNAL FIXATION SYSTEM- BAR/PIN TO BAR/PIN CLAMP
- XTRAFIX SMALL EXTERNAL FIXATION SYSTEM- BROWN HALF PIN
- XTRAFIX SMALL EXTERNAL FIXATION SYSTEM- PIN CLAMP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.