Medical device licence · 95477 · Class 2
ORTHANCHOR
Yes: licensed in Canada
Licence status Issued (active); first licensed July 21, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95477
- Licence holder
- Osstem Implant Co., LtdBusan, South Korea
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 21, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ORTHANCHOR (BRACKET HEAD)
- ORTHANCHOR (SIMPLE HEAD HALF ETCHED)
- ORTHANCHOR (SIMPLE HEAD)
- ORTHANCHOR (SMALL HEAD)
- ORTHANCHOR (THROUGH HOLE HALF ETCHED)
- ORTHANCHOR (THROUGH HOLE)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.