Medical device licence · 11965 · Class 3
FUSION DEVICE - TITANIUM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 16, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11965
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- September 16, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- INTER FIX THREADED FUSION DEVICE
- L-T-CAGE LUMBAR TAPERED FUSION DEVICE
- LIFT VB SPINAL SYSTEM
- LORDOTEC TAPERED FUSION DEVICE
- NOVUS LT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.