Medical device licence · 87152 · Class 3
AXIALIF SYSTEM
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed September 13, 2011; ended April 15, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 87152
- Licence holder
- Baxano Surgical Inc.Raleigh, NC, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 13, 2011
- Ended
- April 15, 2015
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXIALIF SYSTEM - ANCHOR
- AXIALIF SYSTEM - ENDPLATE RASPS
- AXIALIF SYSTEM - IMPLANT
- AXIALIF SYSTEM - IMPLANT PLUG
- AXIALIF SYSTEM - REUSABLE INSTRUMENTATION
- AXIALIF SYSTEM - SINGLE USE INSTRUMENTATION KIT
- AXIALIF SYSTEM - TIGHT DISC CUTTERS
- AXIALIF SYSTEM - TISSUE EXTRACTORS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.