Medical device licence · 65134 · Class 2
REAMERS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 9, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65134
- Licence holder
- Howmedica Osteonics CorporationMahwah, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 9, 2004
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXIAL REAMER
- CEMENTED STEM REAMER
- EXETER MEDULLARY REAMER
- FACING REAMERS
- MONOGRAM KNEE DURACON REVISION STABILIZER OFFSET REAMER
- PASSPORT KNEE INSTRUMENTATION REAMER DRIVER
- PRESSFIT REAMERS
- RECESSED PATELLA REAMER
- SPECIALTY DURACON INSET PATELLA REAMING CUTTER
- SPECIALTY FEMORAL REAMERS
- SPECIALTY PATELLA REAMER CUTTER
- STRYKER TIBIAL STEM REAMER
- TCG REAMER
- TIBIAL BOSS REAMER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.