Medical device licence · 104157 · Class 3
AEQUALIS REVERSED ADAPTER
Yes: licensed in Canada
Licence status Issued (active); first licensed January 15, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104157
- Licence holder
- Tornier S.A.S.Montbonnot-Saint-Martin, France
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 15, 2020
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AEQUALIS REVERSED ADAPTER - HUMERAL TRIAL INSERT
- AEQUALIS REVERSED FX / ADAPTER LATERALIZED HUMERAL INSERT
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 “aequalis”. A notice may cover another product or only some lots: read it to see what it covers.
- Aequalis® Flex Revive® Assembly ScrewJune 21, 2023 · Orthopaedics · Labelling and packaging · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.