Medical device licence · 104610 · Class 3
YUKON OCT SPINAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 9, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104610
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 9, 2020
- Devices covered
- 49
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADJUSTABLE DRILL
- ADJUSTABLE DRILL GUIDE
- ANTI-TORQUE ALIGNMENT TUBE
- AXIAL CONNECTOR
- AXIAL ROD CONNECTOR
- CONTOURED ROD
- CONTOURED ROD COCR
- DUAL LEAD TAP
- FIXED DRILL GUIDE
- HEAD TO HEAD CONNECTOR NUT
- HEAD TO HEAD CONNECTOR PLATE
- HEAD TO HEAD CONNECTOR SET SCREW
- LATERAL OFFSET CONNECTOR
- LATERAL OFFSET CONNECTOR SIDE LOADING ANGLED
- LATERAL OFFSET CONNECTOR, OPEN
- MINI DEFORMITY HOOK ANGLED LEFT
- MINI DEFORMITY HOOK ANGLED RIGHT
- MINI DEFORMITY HOOK INFRALAMINAR
- MINI DEFORMITY HOOK PEDICLE
- OCCIPITAL ANTI-TORQUE GUIDE
- OCCIPITAL PLATE
- OCCIPITAL PLATE TEMPLATE
- OCCIPITAL SCREW
- OCCIPITAL TAP / SCREW GUIDE
- PARALLEL CONNECTOR OPEN
- PARALLEL CONNECTOR SIDE
- PARALLEL CONNECTOR SIDE/CLOSED
- PARALLEL CONNECTOR, CLOSED
- PARALLEL CONNECTOR, OPEN/CLOSED
- PARALLEL ROD CONNECTOR
- POLYAXIAL SCREW
- POLYAXIAL SCREW LONG SHANK
- POLYAXIAL SCREW ML
- POLYAXIAL SCREW, ML DUAL LEAD
- POSTERIOR CERVICAL HOOK ML TP
- POSTERIOR CERVICAL HOOK TP
- POSTERIOR CERVICAL HOOK, LAMINAR
- POSTERIOR CERVICAL HOOK, LAMINAR ML
- PRE BENT ROD 115 DEGREE
- PRE BENT ROD 115 DEGREE COCR
- SET SCREW
- STRAIGHT ROD - TI
- STRAIGHT ROD, DUAL HEX COCR
- TAP GUIDE
- TORQUE LIMITING HANDLE
- TORQUE LIMITING SHAFT
- TRANSITION ROD
- TRANSVERSE CONNECTOR HOOK
- TRANSVERSE CONNECTOR T-BAR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.