Medical device licence · 73083 · Class 3
VERTEX MAX RECONSTRUCTION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 11, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 73083
- Licence holder
- Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 11, 2007
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VERTEX MAX RECONSTRUCTION SYSTEM - CORTICAL SCREW
- VERTEX MAX RECONSTRUCTION SYSTEM - CROSSLINK PLATE CONNECTOR
- VERTEX MAX RECONSTRUCTION SYSTEM - LAMINAR HOOK
- VERTEX MAX RECONSTRUCTION SYSTEM - LATERAL OFFSET CONNECTOR - OPEN
- VERTEX MAX RECONSTRUCTION SYSTEM - MULTI AXIAL SCREW
- VERTEX MAX RECONSTRUCTION SYSTEM - OFFSET LAMINAR HOOK
- VERTEX MAX RECONSTRUCTION SYSTEM - PARTIALLY THREADED MULTI AXIAL SCREW
- VERTEX MAX RECONSTRUCTION SYSTEM - PRECURVED OC ROD
- VERTEX MAX RECONSTRUCTION SYSTEM - ROD
- VERTEX MAX RECONSTRUCTION SYSTEM - ROD CONNECTOR
- VERTEX MAX RECONSTRUCTION SYSTEM - SCREW CONNECTOR
- VERTEX MAX RECONSTRUCTION SYSTEM - THREADED ROD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.