Medical device licence · 11775 · Class 3
DURALOC ACETABULAR CUP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 13, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11775
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 13, 1999
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DURALOC +4 LINER
- DURALOC 100 SERIES SHELL
- DURALOC 1200 SERIES HYLAMER CUP
- DURALOC 300 SERIES CUP
- DURALOC 300 SERIES SHELL
- DURALOC ACETABULAR CUP SYSTEM - MARATHON PE LINERS
- DURALOC BANTAM ACETABULAR CUP SYSTEM DYNAMIC LOCKING RING
- DURALOC BANTAM ACETABULAR CUP SYSTEM ENDURON POLYETHYLENE 10 DEGREE LIP LIN
- DURALOC BANTAM ACETABULAR CUP SYSTEM TITANIUM SHELL (WITH HOLES)
- DURALOC CONSTRAINED ACETABULAR LINER RING
- DURALOC CONSTRAINED LINER
- DURALOC DYNAMIC LOCKING RING
- DURALOC ENDURON POLYETHYLENE LINER - NEUTRAL
- DURALOC HYLAMER POLYETHYLENE LINER - NEUTRAL
- DUROLOC ACETABULAR CUP SYSTEM - 400 SERIES APEX HOLE ELIMINATOR POSITIVE ST
- DUROLOC ACETABULAR CUP SYSTEM - SHELL 400 SERIES TITANIUM POROUS COATING
- FIXED POLYETHYLENE ID TRI-LOCK ACETABULAR CUP
- GEMINI SHELLS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.