Medical device licence · 12183 · Class 3
UNIVERSAL SPINE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 20, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 12183
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 20, 1999
- Devices covered
- 32
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TI CLICK'X REDUCTION SPONDYLOLISTHESIS PEDICLE SCREW
- TITANIUM USS VAS PEDICLE SCREW
- UNIVERSAL SPINE SYSTEM
- UNIVERSAL SPINE SYSTEM - TITANIUM PEDICLE HOOK
- UNIVERSAL SYSTEM TI HARD ROD
- USS BAR FOR TRANS-CONNECTOR
- USS CLAMP
- USS CLAMP ASSEMBLY
- USS CLAMP WITH NUT
- USS COLLAR
- USS COMPRESSION SPRING
- USS CONNECTOR
- USS HOC PLATE
- USS HOOK
- USS HOOK/ROD/CLAMP
- USS INSTRUMENT SET
- USS LOCKING RING
- USS NUT/WASHER
- USS RING
- USS ROD
- USS SCREW
- USS SCREW SET
- USS STAPLE
- USS TI CLICKX PEDICLE SCREW
- USS TITANIUM LOCKING PLATE SET
- USS TITANIUM THORACOLUMBAR
- USS TITANIUM UNIVERSAL SPINE SYSTEM
- USS TITANIUM VARIABLE AXIS SCREW (VAS)
- USS TITANIUM VARIABLE AXIS SCREW - DUAL-CORE
- USS TRANS-CONNECTOR CLAMP BODY
- USS TRANSVERSE BAR
- USS TRANSVERSE PROCESS HOOK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.