Medical device licence · 14969 · Class 3
HYDROXYLAPATITE INCUS PROSTHESES
Yes: licensed in Canada
Licence status Issued (active); first licensed December 2, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 14969
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- December 2, 1999
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- APPLEBAUM INCUS REPLACEMENT SYSTEM - HYDROXYLAPATITE
- APPLEBAUM INCUSOSTAPEDIAL JOINT - HYDROXYLAPATITE
- KARTUSH INCUS STRUT - HYDROXYLAPATITE
- WEHRS INCUS DOUBLE NOTCH - HYDROXYLAPATITE
- WEHRS INCUS SINGLE NOTCH - HYDROXYLAPATITE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.