Medical device licence · 83068 · Class 2
TMT KNEE PROVISIONALS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 16, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83068
- Licence holder
- Zimmer Trabecular Metal Technology, Inc. Also Doing Business As Zimmer And ImplexParsippany, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 16, 2010
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NEXGEN COMPLETE KNEE SOLUTION AUGMENTATION PATELLA PROVISIONAL
- NEXGEN COMPLETE KNEE SOLUTION FEMORAL CONE AUGMENT PROVISIONAL
- NEXGEN COMPLETE KNEE SOLUTION MONOBLOCK TIBIAL PROVISIO/DRILL GUIDE TIBIAL
- NEXGEN COMPLETE KNEE SOLUTION STANDARD POROUS PATELLA PROVISIONAL
- TRABECULAR METAL CONE PROVISIONAL
- TRABECULAR METAL DIAPHYSEAL FEMORAL CONE PROVISIONAL
- TRABECULAR METAL LARGE TIBIAL CONE PROVISIONAL
- TRABECULAR METAL MEDIUM TIBIAL CONE PROVISIONAL
- TRABECULAR METAL MEDIUM TIBIAL CONE SIZING TEMPLATE
- TRABECULAR METAL METAPHYSEAL FEMORAL CONE PROVISIONAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.