Medical device licence · 10461 · Class 3
OMEGA COMPRESSION HIP SCREW SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 24, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 10461
- Licence holder
- Stryker GmbhSelzach, SO, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 24, 1999
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DRILL SLEEVE 3.2MM DIAMETER SUPRACONDYLAR
- GUIDE PIN REPLACEMENT INSTRUMENT
- OMEGA BARREL REAMER ASSEMBLY
- OMEGA COMBINATION REAMER SHAFT
- OMEGA COMPRESSION HIP SCREW SYSTEM - SUPER LAG SCREWS
- OMEGA DRILL GUIDE HANDLE
- OMEGA GUIDE PIN COCR
- OMEGA PLUS STANDARD LAG SCREW
- OMEGA POWER DRIVER BIT
- OMEGA TAP GUIDE
- ONE-STEP INSERTION SLEEVE
- SUPRACONDYLAR ANGLE GUIDE 95 DEGREE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.