Medical device licence · 11816 · Class 3
TITANIUM BONE SCREWS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 14, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11816
- 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
- Device Family
- First licensed
- September 14, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FIXED LOCKING SCREW (NON-STERILE / MAY BE RE-STERILIZED)
- FIXED LOCKING SCREW (STERILE / MAY BE RE-STERILIZED)
- KAESSMANN TRANSVERSE SCREW
- NON-LOCKING SCREW (STERILE / MAY BE RE-STERILIZED)
- TITANIUM ACETABULAR SCREW
- TITANIUM BONE SCREW LOW PROFILE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.