Medical device licence · 10952 · Class 3
SYSTEM 12
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 30, 1999; ended January 19, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 10952
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 30, 1999
- Ended
- January 19, 2004
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HOWMEDICA SYSTEM 12 - APICAL HOLE PLUG
- HOWMEDICA SYSTEM 12 - VITALOCK TALON SHELL
- SYSTEM 12 - ACETABULAR INSERTS
- SYSTEM 12 - ACETABULAR INSERTS (DURATION)
- SYSTEM 12 - ACETABULAR INSERTS - LATERALIZED
- SYSTEM 12 - CROSSFIRE POLYETHYLENE ACETABULAR INSERT - 22MM
- SYSTEM 12 - OSEOLOCK NP OUTER SHELL ACETABULAR COMPONENTS
- SYSTEM 12 - OSTELOCK HA SHELL
- SYSTEM 12 - PRECISION OSTEOLOCK TOTAL HIP
- SYSTEM 12 - VITALOCK SUP SYSTEM - CLUSTER CUP, SOLID BACK CUP, BONE SCREW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.