Medical device licence · 62665 · Class 3
OSSICULAR REPLACEMENT PROSTHESIS (HYDROXYLAPATITE)
Yes: licensed in Canada
Licence status Issued (active); first licensed June 9, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 62665
- Licence holder
- Grace Medical, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 9, 2003
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- H/A FOOTPLATE SHOE OSSICULAR PROSTHESIS
- H/A PARTIAL PROSTHESIS
- H/A PARTIAL STRUT PROSTHESIS
- H/A TOTAL PROSTHESIS
- H/A TOTAL STRUT PROSTHESIS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.