Medical device licence · 104600 · Class 3
T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 4, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104600
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 4, 2020
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CENTERPIECE
- CENTERPIECE (STERILE)
- END CAP FOR CENTERPIECE
- END CAP FOR CENTERPIECE (STERILE)
- EXTENDED END CAP FOR CENTERPIECE
- EXTENDED END CAP FOR CENTERPIECE (STERILE)
- NAVIGATED EXTENDED TEMPLATE
- NAVIGATED INSERTER
- NAVIGATED TEMPLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.