Medical device licence · 95359 · Class 3
TITANIUM - PLATES
Yes: licensed in Canada
Licence status Issued (active); first licensed June 25, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95359
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 25, 2015
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLOVERLEAF PLATE
- LCP DISTAL HUMERUS PLATE, TITANIUM
- TI LCP PROXIMAL HUMERUS PLATE
- TI LOCKING RECON PLATE WITH CONDYLAR HEAD
- TI RECONSTRUCTION STRAIGHT PLATE
- TI SEMI-TUBULAR PLATE
- TITANIUM LOCK REC. PLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.