Medical device licence · 98348 · Class 3
EVOLUTION BIOFOAM TIBIAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 11, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98348
- Licence holder
- Microport Orthopedics Inc.Arlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 11, 2017
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EVOLUTION BIOFOAM PRESSFIT KEEL
- EVOLUTION BIOFOAM TIBIAL BASE PLUS SCREWLESS
- EVOLUTION BIOFOAM TIBIAL BASE PLUS W/SCREWHOLES
- EVOLUTION BIOFOAM TIBIAL BASE SCREWLESS
- EVOLUTION BIOFOAM TIBIAL BASE W/SCREWHOLES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.