Medical device licence · 109274 · Class 3
ORTHOPAEDIC CABLE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 2, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109274
- Licence holder
- Pioneer Surgical Technology Inc.Marquette, MI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 2, 2023
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CABLE WITH CRIMP STERILE
- CANNULATED HEX CERCLAGE BUTTON-STERILE
- CANNULATED HEX TI CERCLAGE BUTTON-STERILE
- DOUBLE NEEDLE CABLE WITH CRIMP STERILE
- HEX CERCLAGE BUTTON-STERILE
- HEX TI CERCLAGE BUTTON-STERILE
- TITANIUM CABLE CRIMP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.