Medical device licence · 100169 · Class 3
VARIABLE ANGLE LOCKING HAND SYSTEM - TITANIUM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 14, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 100169
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 14, 2017
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CORTEX SCREWS, SELF-TAPPING WITH STARDRIVE RECESS, TITANIUM ALLOY, NON-STERILE
- CORTEX SCREWS, SELF-TAPPING WITH STARDRIVE RECESS, TITANIUM ALLOY, STERILE
- LOCKING PLATES, TITANIUM, NON-STERILE
- LOCKING PLATES, TITANIUM, STERILE
- LOCKING SCREWS, SELF-TAPPING WITH STARDRIVE RECESS, TITANIUM ALLOY, NON-STERILE
- LOCKING SCREWS, SELF-TAPPING WITH STARDRIVE RECESS, TITANIUM ALLOY, STERILE
- TI CORTEX SCREW SELF-TAPPING WITH STARDRIVE RECESS, NON-STERILE
- VA LOCKING SCREWS, TITANIUM ALLOY, NON-STERILE
- VA LOCKING SCREWS, TITANIUM ALLOY, STERILE
- VARIABLE ANGLE LOCKING PLATES, TITANIUM, NON-STERILE
- VARIABLE ANGLE LOCKING PLATES, TITANIUM, STERILE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.