Medical device licence · 61844 · Class 3
BIOSTEON ACL HA/PLLA INTERFERENCE SCREW SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 12, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 61844
- Licence holder
- Biocomposites Ltd.Keele, ST, United Kingdom
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 12, 2003
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOSTEON ACL H/PLLA INTERFERENCE SCREW SYSTEM - WEDGE INT. SCREW
- BIOSTEON ACL HA/PLLA INTERFACE SCREW SYSTEM - INTERFERENCE SCREWS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.