Medical device licence · 105170 · Class 3
BANDLOC SPINAL FIXATION
Yes: licensed in Canada
Licence status Issued (active); first licensed September 18, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105170
- Licence holder
- Orthopediatrics CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 18, 2020
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BANDLOC 5.5 / 6.0 IMPLANT BUNDLE
- BANDLOC DUO 5.5 / 6.0 IMPLANT BUNDLE
- REDUCTION DRIVER, SHORT
- SET SCREW DRIVER, BAND-LOC
- SET SCREW, LARGE
- TORQUE LIMITING DRIVER 95 IN-LBS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.