Medical device licence · 68376 · Class 3
SILO SPINAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 12, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 68376
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 12, 2005
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TSRH SILO SPINAL SYSTEM - FIXED AXIS SCREW FOR ROD - TI
- TSRH SILO SPINAL SYSTEM - FRONT LOADING LAMINAR HOOK FOR ROD - TI
- TSRH SILO SPINAL SYSTEM - LATERAL
- TSRH SILO SPINAL SYSTEM - LEFT LAMINAR HOOK FOR ROD -TI
- TSRH SILO SPINAL SYSTEM - LEFT LATERAL OFFSET HOOK FOR ROD - TI
- TSRH SILO SPINAL SYSTEM - LEFT NARROW LAMINAR HOOK FOR ROD - TI
- TSRH SILO SPINAL SYSTEM - LEFT PEDICLE HOOK WITH SCREW ROD - TI
- TSRH SILO SPINAL SYSTEM - LEFT THORACIC HOOK FOR ROD - TI
- TSRH SILO SPINAL SYSTEM - LOCKSCREW - TI
- TSRH SILO SPINAL SYSTEM - MULTI-AXIAL SCREW FOR ROD - TI
- TSRH SILO SPINAL SYSTEM - RIGHT LAMINAR HOOK FOR ROD -TI
- TSRH SILO SPINAL SYSTEM - RIGHT LATERAL OFFSET HOOK FOR - TI
- TSRH SILO SPINAL SYSTEM - RIGHT PEDICLE HOOK WITH SCREW FOR RID - TI
- TSRH SILO SPINAL SYSTEM - RIGHT THORACIC HOOK FOR ROD - TI
- TSRH SILO SPINAL SYSTEM - SAGITTAL ADJUSTING SCREW FOR ROD - TI
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.