Medical device licence · 65222 · Class 3
TRABECULAR METAL KNEE AUGMENTATION COMPONENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 20, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65222
- Licence holder
- Zimmer Trabecular Metal Technology, Inc. Also Doing Business As Zimmer And ImplexParsippany, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- July 20, 2004
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TRABECULAR METAL CONE, FULL
- TRABECULAR METAL CONE, STEPPED
- TRABECULAR METAL DISTAL FEMORAL AUGMENT
- TRABECULAR METAL DISTAL ONLY FEMORAL AUGMENT
- TRABECULAR METAL FOR NEXGEN FULL BLOCK TIB AUGMENT
- TRABECULAR METAL POSTERIOR FEMORAL AUGMENT
- TRABECULAR METAL TIBIAL AUGMENT BLOCK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.