Medical device licence · 16033 · Class 3
AMK TOTAL KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 18, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 16033
- Licence holder
- Depuy Orthopaedics, Inc.Warsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 18, 2000
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMK TOTAL KNEE - ALL POLY POSTERIOR STABILIZED TIBIAL
- AMK TOTAL KNEE - CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT
- AMK TOTAL KNEE - CONSTRAINED TIBIAL INSERT
- AMK TOTAL KNEE - PRIMARY LOCKING PIN
- AMK TOTAL KNEE - VF TIBIAL CLIP
- AMK TOTAL KNEE SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.