Medical device licence · 83103 · Class 2
LINER PROVISIONALS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 21, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83103
- Licence holder
- Zimmer Inc.Winterthur, SZ, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 21, 2010
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIPOLAR TRIAL
- EPSILON ACETABULAR SYSTEM CONSTRAINED INSERT TRIALS
- INTER-OP ACETABULAR SYSTEM HOODED TRIAL INSERTS
- INTER-OP ACETABULAR SYSTEM STANDARD TRIAL INSERTS
- MODULAR ACETABULAR SYSTEM LINER PROVISIONALS ELEVATED RIM
- MODULAR ACETABULAR SYSTEM LINER PROVISIONALS OFFSET
- MODULAR ACETABULAR SYSTEM LINER PROVISIONALS STANDARD
- MULTIPOLAR BIPOLAR CUP PROVISIONAL LINER
- MULTIPOLAR BIPOLAR CUP PROVISIONAL LINERS
- TRABECULAR METAL ACETABULAR REVISION CEMENTED CONSTRAINED LINER PROVISIONAL
- TRABECULAR METAL ACETABULAR REVISION SYST REVISION SHELL LINER PROVISIONAL
- TRILOGY LONGEVITY CONSTRAINED LINER PROVISIONALS
- VERSYS HIP SYSTEM PROVISIONAL ENDO HEAD LINERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.