Medical device licence · 61800 · Class 3
NEXGEN KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 11, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 61800
- 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
- System
- First licensed
- February 11, 2003
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NEXGEM-TM PRIMARY PATELLA
- NEXGEN-TM AUGMENTATION PATELLA
- NEXGEN-TM CR TIBIAL COMPONENT
- NEXGEN-TM LPS TIBIAL COMPONENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.