Medical device licence · 106343 · Class 3
CAPSTONE CONTROL SPINAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 6, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106343
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 6, 2021
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CAPSTONE CONTROL SPINAL SYSTEM
- CAPSTONE CONTROL SPINAL SYSTEM CAM SPREADER TRIAL
- CAPSTONE CONTROL SPINAL SYSTEM LONG INSERTER OUTER SLEEVE
- CAPSTONE CONTROL SPINAL SYSTEM LONG INSERTER THREADED SHAFT
- CAPSTONE CONTROL SPINAL SYSTEM LONG TAPPING EXTRACTOR
- CAPSTONE CONTROL SPINAL SYSTEM SHORT INSERTER OUTER SLEEVE
- CAPSTONE CONTROL SPINAL SYSTEM SHORT INSERTER THREADED SHAFT
- CAPSTONE CONTROL SPINAL SYSTEM SHORT TAPPING EXTRACTOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.