Medical device licence · 104783 · Class 3
RESPONSE SPINE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 17, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104783
- Licence holder
- Orthopediatrics CorporationWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 17, 2020
- Devices covered
- 74
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADJUSTABLE CROSS CONNECTOR
- CANNULATED LENKE PROBE HOUSING
- CANNULATED LENKE PROBE INSERT
- CANNULATED PEDICLE SCREW DRIVER
- CANNULATED POLYAXIAL REDUCTON SCREW
- CANNULATED POLYAXIAL SCREW
- CANNULATED TAP
- CLOSED LATERAL (1 SCREW)
- CLOSED SCREW CAP
- CLOSED STOPPER
- DOMINO CONNECTOR
- DOMINO CONNECTOR OFFSET
- ELEVATED POLYAXIAL LATERAL CONNECTOR
- FIXED CROSS CONNECTOR
- FIXED PEDICLE SCREW
- GUIDE WIRE, BLUNT
- HOOK HOLDER
- HUDSON TO 1/4 SQ. ADAPTER
- INLINE CONNECTOR
- LENKE PROBE, CURVED, NAVIGATION
- LENKE PROBE, STRAIGHT, NAVIGATION
- MINI REDUCER
- NAV GUIDE WINDOW TAP
- OPEN 40 DEG OFFSET HOOK
- OPEN EXTENDED BODY LEFT OFFSET THORACIC HOOK
- OPEN EXTENDED BODY RIGHT OFFSET THORACIC HOOK
- OPEN EXTENED BODY THORACIC HOOK
- OPEN LAMINAR HOOK
- OPEN LATERAL CONNECTOR
- OPEN LATERAL CROSS CONNECTOR
- OPEN LEFT OFFSET LUMBAR HOOK
- OPEN LEFT OFFSET THORACIC HOOK
- OPEN PEDICLE HOOK
- OPEN RIGHT OFFSET LUMBAR HOOK
- OPEN RIGHT OFFSET THORACIC HOOK
- OPEN THORACIC HOOK
- OPEN/ CLOSED WEDDING BAND
- OPEN/ OPEN DOMINO CONNECTOR
- OPEN/ OPEN WEDDING BAND
- OPEN/ OPEN WEDDING BAND W/ SPACER
- PEDICLE SCREW DRIVER
- PEDICLE SCREW DRIVER, NAVIGATION
- POLYAXIAL PEDICLE SCREW
- POLYAXIAL REDUCTION SINGLE LEAD PEDICLE SCREW
- POLYAXIAL SINGLE LEAD PEDICLE SCREW
- POWER TORQUE LIMITER COUNTER TORQUE
- PRE-BENT ROD, COCR
- QUICK GRAB PLIERS
- REDUCTION DRIVER
- REDUCTION PEDICLE SCREW DRIVER
- REDUCTION PEDICLE SCREW DRIVER, NAVIGATION
- REDUCTION POLYAXIAL PEDICLE SCREW
- ROD COCR
- ROD TI ALLOY
- ROD, COCR, DUAL HEX
- ROD, COCR, SINGLE HEX
- ROD, TI, SINGLE HEX
- S-ROD
- S-ROD, COCR
- SCREW BODY EXTENSION
- SCREW OPEN LATERAL
- SET SCREW
- SET SCREW TORQUE LIMITER
- TAP, CANNULATED, NAVIGATION
- TAP, NAVIGATION
- TAP, SINGLE LEAD, NAVIGATION
- TORQUE LIMITING DRIVER
- TRANSITION ROD COCR ALLOY
- UNIAXIAL PEDICLE SCREW
- UNIAXIAL REDUCTION PEDICLE SCREW
- UNIAXIAL REDUCTION SINGLE LEAD PEDICLE SCREWS
- UNIAXIAL SINGLE LEAD PEDICLE SCREWS
- WEDDING BAND CONNECTOR
- WEDDING BAND CONNECTOR OFFSET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.