Medical device licence · 95438 · Class 3
UNIVERSAL SPINE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 10, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95438
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 10, 2015
- Devices covered
- 36
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3.0MM NUT FOR SPONDYLOLYSIS HOOKS
- 4.0MM SPONDYLOLYSIS SCREW
- 4.0MM TI SCHANZ SCREW
- 5.0MM TI SCHANZE SCREW, BLUNTED TROCAR POINT
- 5.0MM TI SIDE-OPENING SCREW
- 6.0MM SOFT ROD
- 6.0MM SPONDYLOLYSIS HOOK
- 6.0MM TI CURVED SOFT ROD
- 6.0MM TI SCHANZ SCREW DIAMOND POINT
- 6.2MM TI CLICK'X PEDICLE SCREW
- 6.2MM TI PRE-ASSEMBLED VARIABLE AXIS SCREW
- 6.2MM TI SCHANZ SCREW
- 7.0MM FULLY THREADED ROD
- 7.0MM TI CLICK'X PEDICLE SCREW
- ANCHORING HOOK
- ANCHORING RING
- CLAMP W/LATERAL NUT
- CLAMP W/POSTERIOR NUT
- COMPRESSION SPRING
- CROSS LINK ROD
- HOOK
- LOCKING HOOK SPINAL ROD ASSY FULLY THREADED
- NUT FOR 7.0MM THREADED RODS
- SLIDING HOOK COVER
- TI EXTENSION CONNECTOR
- TI NUT 11MM
- TI SCHANZ SCREW, SHORT THREAD-BLUNTED
- TI WASHER
- TITANIUM PEDICLE HOOK
- TRANS-CONNECTOR CLAMP
- UNIVERSAL SYSTEM TI HARD ROD
- USS CONNECTOR
- USS NUT/WASHER
- USS ROD
- USS SCREW
- WASHER FOR NUT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.