Medical device licence · 64015 · Class 3
PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 23, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64015
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- March 23, 2004
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PEEK PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT(S)
- TITANIUM PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT(S) - CUSTOM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.