Medical device licence · 100447 · Class 3
ES2 AUGMENTABLE SPINAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 25, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100447
- Licence holder
- Stryker SpineAllendale, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 25, 2018
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ES2 AUGMENTABLE BLADE DELIVERY UNIT
- ES2 AUGMENTABLE FENESTRATED LONG BLADE MONOAXIAL SCREW WITH BLOCKER
- ES2 AUGMENTABLE FENESTRATED LONG BLADE POLYAXIAL SCREW WITH BLOCKER
- ES2 AUGMENTABLE FENESTRATED SHORT BLADE MONOAXIAL SCREW WITH BLOCKER
- ES2 AUGMENTABLE FENESTRATED SHORT BLADE POLYAXIAL SCREW WITH BLOCKER
- ES2 AUGMENTABLE MONOAXIAL SCREWDRIVER NAVIGATED
- ES2 AUGMENTABLE TI HEX RAD ROD
- ES2 AUGMENTABLE TI HEX STRAIGHT ROD
- ES2 AUGMENTABLE TULIP DELIVERY UNIT
- ES2 AUGMENTABLE VITALLIUM HEX STRAIGHT ROD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.