Medical device licence · 80760 · Class 3
IBALANCE OPENING WEDGE OSTEOTOMY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 29, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80760
- Licence holder
- Arthrex IncNaples, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 29, 2009
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IBALANCE, HTO SYSTEM - AKR FIXATION PIN
- IBALANCE, HTO SYSTEM - ANCHOR DRILL
- IBALANCE, HTO SYSTEM - HTO ANCHOR, CANCELLOUS
- IBALANCE, HTO SYSTEM - HTO ANCHOR, CORTICAL
- IBALANCE, HTO SYSTEM - HTO IMPLANT
- IBALANCE, HTO SYSTEM - KEYHOLE REAMER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.