Medical device licence · 94205 · Class 3
FENESTRATED SCREW CEMENT
Yes: licensed in Canada
Licence status Issued (active); first licensed November 14, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94205
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- November 14, 2014
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FENESTRATED SCREW CEMENT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “fenestrated”. A notice may cover another product or only some lots: read it to see what it covers.
- 8mm, Tip-Up Fenestrated Grasper, IS4000June 20, 2023 · Gastroenterology and urology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.