Medical device licence · 91846 · Class 3
ES2 AND MANTIS SPINAL SYSTEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed August 20, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91846
- Licence holder
- Stryker SpineAllendale, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 20, 2013
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CANNULATED MODULAR TAP
- CANNULATED MODULATAR AWL
- ES2 SPINAL SYSTEM - CANNULATED LONG BLADE SCREW
- ES2 SPINAL SYSTEM - CANNULATED SHORT BLADE SCREW
- ES2 SPINAL SYSTEM - TI HEX RAD ROD
- ES2 SPINAL SYSTEM - TI HEX STRAIGHT ROD
- ES2 SPINAL SYSTEM - VITALLIUM STRAIGHT ROD
- LITE BLOCKER
- POLYAXIAL SCREWDRIVER
- RECOVERY GUIDE
- THREADED RECOVER GUIDE
- TITANIUM HEX RAD ROD
- TITANIUM HEX STRAIGHT ROD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.