Medical device licence · 104071 · Class 3
RESPONSE SPINE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 20, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 104071
- Licence holder
- Orthopediatrics CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 20, 2019
- Devices covered
- 32
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADJUSTABLE CROSS CONNECTOR
- DOMINO CONNECTOR
- FIXED CROSS CONNECTOR
- INLINE CONNECTOR
- LENKE PROBE, CURVED, NAVIGATION
- LENKE PROBE, STRAIGHT, NAVIGATION
- LRG. HUDSON TO 1/4 SQ. ADAPTER
- LRG. SET SCREW
- NAV GUIDE WINDOW TAP
- OPEN 40 DEG OFFSET HOOK
- OPEN LAMINAR HOOK
- OPEN LATERAL CROSS CONNECTOR
- OPEN OFFSET LUMBAR HOOK
- OPEN PEDICLE HOOK
- OPEN THORACIC HOOK
- PEDICLE SCREW DRIVER, NAVIGATION
- POLYAXIAL PEDICLE SCREW DL
- REDUCTION DRIVER SEGMENTAL DEROTATION
- REDUCTION PEDICLE SCREW DRIVER, NAVIGATION
- REDUCTION POLYAXIAL PEDICLE SCREW DL
- ROD TI ALLOY SINGLE HEX
- ROD, COCR, SINGLE HEX
- TAP, CANNULATED, NAVIGATION
- TAP, NAVIGATION
- TAP, SINGLE LEAD, NAVIGATION
- TRANSITION DOMINO CONNECTOR
- TRANSITION ROD COCR ALLOY
- TRANSITION ROD TI ALLOY
- TRANSITION WEDDING BAND CONNECTOR
- UNI PEDICLE SCREW
- UNI REDUCTION SCREW
- WEDDING BAND CONNECTOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.