Medical device licence · 80549 · Class 3
MATRIXRIB FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 27, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80549
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 27, 2009
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MATRIXRIB FIXATION SYSTEM - DRILL BIT WITH STOP
- MATRIXRIB FIXATION SYSTEM - IM SPLINT
- MATRIXRIB FIXATION SYSTEM - IM SPLINT, STERILE
- MATRIXRIB FIXATION SYSTEM - LOCKING SCREW SELF-TAPPING, TI
- MATRIXRIB FIXATION SYSTEM - LOCKING SCREW SELF-TAPPING, TI, STERILE
- MATRIXRIB FIXATION SYSTEM - NON-LOCKING SCREW SELF-TAPPING, TI
- MATRIXRIB FIXATION SYSTEM - NON-LOCKING SCREW SELF-TAPPING, TI, STERILE
- MATRIXRIB FIXATION SYSTEM - PRE-CONTOURED PLATE, TI
- MATRIXRIB FIXATION SYSTEM - SPLINT DRILL GUIDE
- MATRIXRIB FIXATION SYSTEM - THREADED DRILL GUIDE
- MATRIXRIB FIXATION SYSTEM - UNIVERSAL LOCKING PLATE, TI
- MATRIXRIB INTRAMEDULLARY SPLINT TEMPLATE
- SELF-DRILLING SCREW GUIDE FOR MATRIXRIB IM SPLINTS
- SELF-DRILLING SCREW GUIDE FOR MATRIXRIB PLATES
- TI MATRIXRIB LCKNG SCREW SELF-DRILLING
- TI MATRIXRIB LCKNG SCREW SELF-DRILLING STERILE
- TI MATRIXRIB NON-LCKNG SCREW SELF-DRILLING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.