Medical device licence · 32848 · Class 3
MONARCH SPINE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 18, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 32848
- Licence holder
- Medos International SarlLe Locle, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 18, 2001
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MONARCH SPINE SYSTEM - CLOSED HOOK, NARROW BLADE
- MONARCH SPINE SYSTEM - CLOSED HOOK, WIDE BLADE
- MONARCH SPINE SYSTEM - DUAL DIAMETER ROD
- MONARCH SPINE SYSTEM - DUAL ROD CONNECTOR CLOSED END-TO-END
- MONARCH SPINE SYSTEM - DUAL ROD CONNECTOR, CLOSED
- MONARCH SPINE SYSTEM - DUAL ROD CONNECTOR, CLOSED, SIDE-BY-SIDE
- MONARCH SPINE SYSTEM - TITANIUM CONNECTOR
- MONARCH SPINE SYSTEM - TITANIUM NO CUT PEDICLE SCREW
- MONARCH SPINE SYSTEM - TITANIUM NUT
- MONARCH SPINE SYSTEM - TITANIUM PEDICLE SCREW
- MONARCH SPINE SYSTEM - TITANIUM ROD
- MONARCH SPINE SYSTEM - TITANIUM SCREW
- MONARCH SPINE SYSTEM - TITANIUM WASHER
- MONARCH SPINE SYSTEM - TRANSVERSE RODDED CONNECTOR WITH CLOSED VHG BODY
- MONARCYH SPINE SYSTEM - ROD WITH CLOSED VHG BODY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.