Medical device licence · 103971 · Class 2
NEXFRAME SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 2, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103971
- Licence holder
- Fhc, Inc.Bowdoin, ME, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 2, 2019
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BILATERAL NEXFRAME SYSTEM FOR MEDTRONIC STEALTHSTATION NAVIGATION SYSTEMS
- NEXDRIVE MICROPOSITIONING DRIVE
- NEXDRIVE MICROPOSITIONING DRIVE WITH DISPLAY OPTION
- NEXFRAME CRANIAL BONE SCREWS
- NEXPROBE IMAGE-GUIDED PROBE FOR USE WITH NEXFRAME STEREOTACTIC SYSTEM AND MEDTRONIC STEALTHSTATION NAVIGATION SYSTEMS
- UNIBODY BONE FIDUCIALS FOR USE WITH THE NEXFRAME STEREOTACTIC SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.