Medical device licence · 101058 · Class 3
PRIME ACETABULAR CUP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 18, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101058
- Licence holder
- Microport Orthopedics Inc.Arlington, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 18, 2018
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MPO TORX T25 CANCELLOUS BONE SCREW
- PRIME A-CLASS XLPE LINER
- PRIME AM QUAD SHELL
- PRIME AM SOLID SHELL
- PRIME BALL & SOCKET TORX SCREWDRIVER LONG
- PRIME BALL & SOCKET TORX SCREWDRIVER SHORT
- PRIME BIOFOAM QUAD SHELL
- PRIME BIOFOAM SOLID SHELL
- PRIME E-CLASS XLPE LINER
- PRIME FC LAT TRIAL LINER
- PRIME FLEX DRILL BIT
- PRIME FLEXIBLE DRILL SHAFT
- PRIME LINER EXTRACTION DRILL
- PRIME LINER EXTRACTION SCREW
- PRIME LIPPED TRIAL LINER
- PRIME STANDARD TRIAL LINER
- PRIME STRAIGHT TORX SCREWDRIVER LONG
- PRIME STRAIGHT TORX SCREWDRIVER SHORT
- PRIME TRIAL LINER TORX SCREW
- PRIME TRIAL SHELL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.