Medical device licence · 91299 · Class 3
IBALANCE UKA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 14, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91299
- Licence holder
- Arthrex IncNaples, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 14, 2013
- Devices covered
- 31
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANGEL WING, NARROW BODY
- ANKLE CLAMP, EM TIBIAL GUIDE
- HEADED THREADED PIN, SHORT
- IBALANCE TKA, TROCAR PIN SMOOTH
- IBALANCE UKA BASE PLATE TRIALS
- IBALANCE UKA CEMENT REMOVAL TOOL
- IBALANCE UKA DISPOSABLE TIBIAL CUTTING GUIDE, LEFT
- IBALANCE UKA FEMORAL TRIALS
- IBALANCE UKA PIN CADDY
- IBALANCE UKA SYSTEM - IBALANCE UKA, TIBIAL BEARING
- IBALANCE UKA SYSTEM - IBALANCE UNI FEMORAL
- IBALANCE UKA TIBIAL BEARING
- IBALANCE UKA TIBIAL BEARING RING PULLER
- IBALANCE UKA TIBIAL BEARING TRIALS
- IBALANCE UKA TIBIAL STYLUS, ADJUSTABLE
- IBALANCE UKA TIBIAL TRAY, CEMENTED
- IBALANCE UKA TIBIAL TRIAL HANDLE
- IBALANCE UKA, ADJUSTABLE SPACER BLOCK
- IBALANCE UKA, DELTA SCALE ATTACHMENT
- IBALANCE UKA, DISPOSABLE TIBIAL CUTTING GUIDE, RIGHT
- IBALANCE UKA, FEMORAL FINISH GUIDE
- IBALANCE UKA, TIBIA TRIALING SHIM 2/3MM
- IBALANCE UKA, TIBIAL CUT GUIDE, LEFT
- IBALANCE UKA, TIBIAL CUT GUIDE, RIGHT
- IBALANCE UKA, TIBIAL FIXATION BUTTRESS
- IBALANCE UKA, TIBIAL KEEL PUNCH
- IBALANCE UKA, VERTICAL CUT GUIDE, LEFT
- LONG DISTAL BODY, EM TIBIAL GUIDE
- PROXIMAL BODY, EM TIBIAL GUIDE
- SHORT DISTAL BODY, EM TIBIAL GUIDE
- UKA INSTRUMENTATION SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.