Medical device licence · 97104 · Class 3
UCENTUM COMPREHENSIVE POSTERIOR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 14, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97104
- Licence holder
- Ulrich Gmbh & Co. KgUlm, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 14, 2016
- Devices covered
- 63
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTER FOR INJECTION
- ASSEMBLING INSTRUMENT FOR GUIDE SLEEVE
- ASSEMBLING SUPPORT FOR GUIDE SLEEVE
- AWL, CANNULATED
- BENDING HEAD FOR ROD BENDING FORCEPS
- BLADE FOR DISTRACTION AND COMPRESSION FORCEPS
- BLADE PERCUTANEOUS
- COUNTERPART
- CROSSLINK VARIABLE
- CROSSLINK WITH HOOK, VARIABLE
- DILATOR
- FORCEPS
- GEARSHIFT HANDLE
- HANDLE
- HANDLE FOR ADAPTER FOR INJECTION
- HANDLE FOR GUIDE WIRE HOLDER
- HANDLE FOR ROD BENDING FORCEPS
- HANDLE FOR ROD INSERTER
- LAMINA HOOK
- LOCKING SCREW
- LONG ARM SCREW, POLYAXIAL, NOT CANNULATED
- LONGARM SCREW, PRE-FIXATION
- NUT
- OFFSET CONNECTOR FOR ROD
- OUTER SLEEVE FOR GUIDE SLEEVE
- PEDICLE HOOK
- PEDICLE PROBE WITH BALL HANDLE
- PHANTOM ROD
- POSITIONING INSTRUMENT FOR HOOKS
- PREPARATION INSTRUMENT
- PROTECTION SLEEVE
- REDUCTION ARM
- REDUCTION WHEEL
- RETRACTOR FOR PERCUTANEOUS REDUCTION
- ROD BENDING INSTRUMENT
- ROD CLAMP
- ROD HOLDER
- ROD INSERTER
- ROD PUSHER
- ROD PUSHER WITH SPRING
- ROD ROTATOR
- ROD, COCR
- ROD, CURVED
- ROD, STRAIGHT
- SCREW HEAD ADJUSTER
- SCREW, MONOAXIAL
- SCREW, MONOAXIAL, NOT CANNULATED
- SCREW, POLYAXIAL
- SCREW, POLYAXIAL, NOT CANNULATED
- SCREW, PRE-FIXATION
- SCREW, PRE-FIXATION, NOT CANNULATED
- SCREWDRIVER
- SLEEVE FOR LOCKING SCREW
- SLEEVE FOR ROD PUSHER
- SOCKET WRENCH
- STAMP
- STAR GRIP HANDLE
- T-HANDLE WITH RATCHET
- T-HANDLE WITH TORQUE LIMITATION
- TAP
- THREADED ELEMENT FOR GUIDE WIRE HOLDER
- TROCAR WIRE
- TUBE FOR ROD INSERTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.