Medical device licence · 92604 · Class 3
MPACT
Yes: licensed in Canada
Licence status Issued (active); first licensed January 22, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 92604
- Licence holder
- Medacta International SaCastel San Pietro, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 22, 2014
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DOUBLE MOBILITY ACETABULAR SHELL
- MPACT 3D METAL MONOCER ACETABULAR SHELL AND LINER
- MPACT ACETABULAR SHELL CENTRAL SCREW PLUG
- MPACT CANCELLOUS BONE SCREW
- MPACT CEMENTLESS ACETABULAR SHELL MULTI-HOLE
- MPACT CEMENTLESS ACETABULAR SHELL NO-HOLE
- MPACT CEMENTLESS ACETABULAR SHELL RIM-HOLE
- MPACT CEMENTLESS ACETABULAR SHELL TWO-HOLES
- MPACT CORTICAL BONE SCREW
- MPACT FLAT UHMWPE LINER
- MPACT HIGHCROSS FACE-CHANGING UHMWPE LINER
- MPACT HIGHCROSS FLAT UHMWPE LINER
- MPACT HIGHCROSS HOODED UHMWPE LINER
- MPACT HIGHCROSS OFFSET UHMWPE LINER
- MPACT HOODED UHMWPE LINER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.