Medical device licence · 69988 · Class 3
ARCOMXL ACETABULAR LINERS - POLYETHYLENE
Yes: licensed in Canada
Licence status Issued (active); first licensed December 13, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 69988
- Licence holder
- Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet TraumaWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 13, 2005
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARCOMXL MAX-ROM RINGLOC LINER
- ARCOMXL RINGLOC ACETABULAR LINER +3 HI-WALL
- ARCOMXL RINGLOC ACETABULAR LINER +3 MAX-ROM
- ARCOMXL RINGLOC LINER
- FLAT FACE RINGLOC LOCKING ACETABULAR LINER PROVISIONAL
- MAX-ROM RINGLOC PROV. LINER W/ LOCKING SCREW
- MAXROM RINGLOC LOCKING PROVISIONAL LINER W/ LOCKING SCREW ASSEMBLY
- RINGLOC HI-WALL + TRIAL LINER
- RINGLOC MAXROM + TRIAL LINER
- RINGLOC PROVISIONAL ACETABULAR LINER WITH LOCKING SCREW
- RINGLOC SCREW-IN PROVISIONAL LINER W/ LOCKING SCREW ASSEMBLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.