Medical device licence · 92490 · Class 3
XTRAFIX EXTERNAL FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 18, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92490
- Licence holder
- Zimmer Inc.Winterthur, SZ, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 18, 2013
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- XTRAFIX EXTERNAL FIXATION SYSTEM BARS
- XTRAFIX EXTERNAL FIXATION SYSTEM CLAMPS
- XTRAFIX EXTERNAL FIXATION SYSTEM DRILLS
- XTRAFIX EXTERNAL FIXATION SYSTEM HANDLES
- XTRAFIX EXTERNAL FIXATION SYSTEM PINS
- XTRAFIX EXTERNAL FIXATION SYSTEM POSTS
- XTRAFIX EXTERNAL FIXATION SYSTEM THUMBWHEEL
- XTRAFIX EXTERNAL FIXATION SYSTEM TISSUE PROTECTORS
- XTRAFIX EXTERNAL FIXATION SYSTEM TROCARS
- XTRAFIX EXTERNAL FIXATION SYSTEM WRENCHES
- XTRAFIX EXTERNAL FIXATION SYSTEM, HALF PIN
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.