Medical device licence · 81103 · Class 3
ACETABULAR INSERTS (POLYETHYLENE)
Yes: licensed in Canada
Licence status Issued (active); first licensed November 3, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81103
- Licence holder
- Medacta International SaCastel San Pietro, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- November 3, 2009
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DOUBLE MOBILITY HC LINER
- DOUBLE MOBILITY LINER
- HIGHCROSS DOUBLE MOBILITY LINER
- VERSAFITCUP CC FLAT PE INSERT
- VERSAFITCUP CC HIGHCROSS FLAT PE INSERT
- VERSAFITCUP CC HIGHCROSS HOODED PE FIXED INSERT
- VERSAFITCUP CC HOODED PE INSERT
- VERSAFITCUP FIXED PE INSERTS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.