Medical device licence · 38450 · Class 3
VERTEX RECONSTRUCTION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 24, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 38450
- 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 24, 2002
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VERTEX RECONSTRUCTION SYSTEM - CANCELLOUS SCREW TI
- VERTEX RECONSTRUCTION SYSTEM - CANCELLOUS SCREW, TI
- VERTEX RECONSTRUCTION SYSTEM - CORTICAL SCREW, TI
- VERTEX RECONSTRUCTION SYSTEM - CROSS LINK CLIP
- VERTEX RECONSTRUCTION SYSTEM - CROSS LINK CLIP
- VERTEX RECONSTRUCTION SYSTEM - FORAMINAL HOOK
- VERTEX RECONSTRUCTION SYSTEM - LAMINAR HOOK
- VERTEX RECONSTRUCTION SYSTEM - LATERAL CONNECTOR
- VERTEX RECONSTRUCTION SYSTEM - M6 SET SCREW
- VERTEX RECONSTRUCTION SYSTEM - MIDLINE OCCIPITAL PLATE, TI
- VERTEX RECONSTRUCTION SYSTEM - MULTI AXIAL CORTICAL BONE SCREW, TI
- VERTEX RECONSTRUCTION SYSTEM - MULTI-AXIAL CANCELLOUS BONE SCREW, TI
- VERTEX RECONSTRUCTION SYSTEM - OCCIPITAL HOOK, SMALL
- VERTEX RECONSTRUCTION SYSTEM - PRE-CURVED OCCIPITAL PLATE/ROD, TI
- VERTEX RECONSTRUCTION SYSTEM - ROD CONNECTOR TI
- VERTEX RECONSTRUCTION SYSTEM - SCREW CONNECTOR
- VERTEX RECONSTRUCTION SYSTEM - TITANIUM NUT OF OCCIPITAL HOOK
- VERTEX RECONSTRUCTION SYSTEM - TITANIUM ROD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.