Medical device licence · 64423 · Class 2
DRILL BITS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 10, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64423
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 10, 2004
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADJUSTABLE DRILL BIT
- ANGLED DRILL
- ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM - DRILL BIT
- AXIS FIXATION SYSTEM - DRILL BIT
- DRILL
- ORION ANTERIOR CERVICAL PLATE SYSTEM - DRILL BIT
- UNIVERSAL CANNULATED SCREW SET - DRILL BIT
- VERTEX RECONSTRUCTION SYSTEM - DRILL BITS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.