Medical device licence · 70323 · Class 3
TRANSFX EXTERNAL FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 25, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 70323
- Licence holder
- Zimmer Inc.Winterthur, SZ, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 25, 2006
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TRANSFX-ANGLED ROD
- TRANSFX-CARBON FIBER ROD
- TRANSFX-MULTI-PIN CLAMP - END-CONNECT
- TRANSFX-MULTI-PIN CLAMP - MID-CONNECT
- TRANSFX-MULTI-PIN CLAMP - SINGLE-CONNECT
- TRANSFX-OPEN ROD TO ROD CLAMP
- TRANSFX-OPEN UNIVERSAL CLAMP
- TRANSFX-PIN - THREADED
- TRANSFX-PROTECTIVE CAPS
- TRANSFX-QUICK CONNECT TO HEX ADAPTER
- TRANSFX-ROD TO ROD CLAMP
- TRANSFX-ROD TO ROD TRANSITIONAL CLAMP
- TRANSFX-SELF-DRILLING PIN - THREADED
- TRANSFX-SPEED NUT
- TRANSFX-TRANSVERSE PIN WITH CENTRAL THREADS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.