Medical device licence · 87729 · Class 3
MESA SPINAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 1, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 87729
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 1, 2011
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 360 DEGREE SCREW
- DEFORMITY UNI-PLANAR SCREW
- FOUNDATION SCREW
- MESA SPINAL SYSTEM CONTOURED MESA RAIL
- MESA SPINAL SYSTEM, ANGLED TRANSVERSE PROCESS HOOK
- MESA SPINAL SYSTEM, ANGLED TRANSVERSE PROCESS HOOK
- MESA SPINAL SYSTEM, AXIAL CONNECTOR, RAIL
- MESA SPINAL SYSTEM, LAMINAR HOOK
- MESA SPINAL SYSTEM, LAMINAR OFFSET HOOK
- MESA SPINAL SYSTEM, LATERAL OFFSET CONNECTOR, RAIL
- MESA SPINAL SYSTEM, MESA 2 DEFORMITY POLYAXIAL
- MESA SPINAL SYSTEM, MESA 2 DEFORMITY UNIPLANAR
- MESA SPINAL SYSTEM, NATURAL BRIDGE TRANSVERSE CONNECTOR
- MESA SPINAL SYSTEM, PARALLEL CONNECTOR, RAIL
- MESA SPINAL SYSTEM, PEDICLE HOOK
- MESA SPINAL SYSTEM, STRAIGHT RAIL
- MESA SPINAL SYSTEM, TRANSITION RAIL
- MESA SPINAL SYSTEM, TRANSVERSE CONNECTOR
- MESA SPINAL SYSTEM, TRANSVERSE PROCESS HOOK
- POLYAXIAL SCREW ASMBLY
- TRANSVERSE CONNECTOR, ADJUSTABLE
- TRANSVERSE CONNECTOR, SEMI- ADJUSTABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.