Medical device licence · 105661 · Class 3
STERNALOCK XP RIGID FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 29, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105661
- Licence holder
- A & E Medical CorporationFarmingdale, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 29, 2020
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- STERNALOCK XP RIGID FIXATION SYSTEM AUXILIARY CABLE PLATE KIT, SHARP NEEDLE
- STERNALOCK XP RIGID FIXATION SYSTEM BONE SCREW
- STERNALOCK XP RIGID FIXATION SYSTEM BOX CABLE PLATE KIT
- STERNALOCK XP RIGID FIXATION SYSTEM DISPOSABLE CABLE TENSIONER
- STERNALOCK XP RIGID FIXATION SYSTEM DISPOSABLE PLATE CUTTER
- STERNALOCK XP RIGID FIXATION SYSTEM DOUBLE CABLE PLATE KIT
- STERNALOCK XP RIGID FIXATION SYSTEM DOUBLE CABLE PLATE KIT, SHARP NEEDLE
- STERNALOCK XP RIGID FIXATION SYSTEM LADDER CABLE PLATE KIT
- STERNALOCK XP RIGID FIXATION SYSTEM TOWER CABLE PLATE KIT
- STERNALOCK XP RIGID FIXATION SYSTEM X CABLE PLATE
- STERNALOCK XP RIGID FIXATION SYSTEM ZDRIVE BLADE, STERNALOCK XP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.