Medical device licence · 86276 · Class 3
FIBULA ROD SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 7, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86276
- Licence holder
- Acumed, LlcHillsboro, OR, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 7, 2011
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FIBULA ROD SYSTEM - AWL ASSEMBLY
- FIBULA ROD SYSTEM - BASE PLATE ASSEMBLY
- FIBULA ROD SYSTEM - CANNULA
- FIBULA ROD SYSTEM - DRILL
- FIBULA ROD SYSTEM - DRILL GUIDE
- FIBULA ROD SYSTEM - FIBULA ROD
- FIBULA ROD SYSTEM - LOCKING BOLT
- FIBULA ROD SYSTEM - REAMER
- FIBULA ROD SYSTEM - TARGETING GUIDE
- FIBULA ROD SYSTEM - WRENCH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.