Medical device licence · 15357 · Class 3
TSRH SPINAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 20, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 15357
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 20, 1999
- Devices covered
- 28
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TSRH CONNECTOR - SS
- TSRH CONNECTOR - TI
- TSRH CONNECTOR - TI PEDIATRIC
- TSRH CROSSLINK PLATE - SS
- TSRH CROSSLINK PLATE - TI
- TSRH EYEBOLT - TI
- TSRH EYEBOLT ASSEMBLY - SS
- TSRH EYEBOLT/LOCKNUT - TI
- TSRH EYEBOLT/LOCKNUT ASSEMBLY - SS
- TSRH EYEBOLT/LOCKNUT ASSEMBLY TI-PEDIATRIC
- TSRH HOOK - PEDIATRIC - TI
- TSRH HOOK - SS
- TSRH HOOK - TI
- TSRH LOCKNUT -SS
- TSRH OFFSET PLATE - SS
- TSRH PEDIATRIC HOOK - SS
- TSRH ROD - SS
- TSRH ROD - TI
- TSRH SCREW - SS
- TSRH SCREW - TI
- TSRH SCREW SPACER - TI
- TSRH SPINAL SCREWS - SS
- TSRH STAPLE - SS
- TSRH STAPLE - TI
- TSRH T-BOLT - SS
- TSRH T-BOLT - TI
- TSRH TACOMA SACRAL FIXATION PLATE - SS
- TSRH WASHER - SS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.