Medical device licence · 99295 · Class 3
OSSEOTI RECONSTRUCTIVE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 14, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99295
- Licence holder
- Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet TraumaWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 14, 2017
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OSSEOTI RECONSTRUCTIVE SYSTEM, RECONSTRUCTIVE WEDGE
- OSSEOTI RECONSTRUCTIVE SYSTEM, RECONSTRUCTIVE WEDGE TRIAL
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 “osseoti”. A notice may cover another product or only some lots: read it to see what it covers.
- G7 Acetabular Shell 3 Hole Osseoti, CementlessOctober 14, 2022 · 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.