Medical device licence · 104766 · Class 3
EVEREST SPINAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 12, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104766
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 12, 2020
- Devices covered
- 52
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 1 LEVEL KIT, RETRACTORS/WIRES
- ADD ON KIT, RETRACTORS/WIRES
- ALIGNMENT GUIDE
- ANTI TORQUE ALIGNMENT TUBE
- AXIAL ROD CONNECTOR
- CANNULATED PROBE
- COCR STRAIGHT ROD, BULLETED HEX
- COCR STRAIGHT ROD, DUAL HEX
- CONTOURED ROD, BULLETED HEX
- DUAL HEX COCR CONTOURED DEFORMITY ROD
- DUAL HEX TI CONTOURED DEFORMITY ROD
- FENESTRATED, POLYAXIAL SCREW
- GUIDEWIRE
- GUIDEWIRE PACK
- LAMINAR HOOK
- LATERAL CONNECTOR, SIDE LOADING
- LATERAL OFFSET CONNECTOR
- LUMBAR LAMINAR HOOK
- LUMBAR LAMINAR HOOK, OFFSET
- LUMBAR PROBE
- NEEDLE PACK, SHORT
- NITI GUIDEWIRE
- OFFSET ROD
- PEDICLE HOOK
- PLUNGER PACK, SHORT
- POLYAXIAL SCREW
- POLYAXIAL SCREW, CANNULATED
- POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED
- PORT SHIM
- ROD CONNECTOR
- SACROILIAC SCREW
- SACROILIAC SCREW, CANNULATED
- SACROILIAC SCREW, EXTENDED TAB, FENESTRATED
- SET SCREW
- SIZE (S) TRANSVERSE PROCESS HOOK
- SLOTTED PORT
- SLOTTED PORT BEVELED
- SS GUIDEWIRE
- STRAIGHT ILIAC PROBE
- STYLET
- STYLET SPECIAL CONNECTOR
- THORACIC LAMINAR HOOK
- THORACIC PROBE
- TI CONTOURED ROD
- TI STRAIGHT ROD
- TI STRAIGHT ROD, BULLETED HEX
- TI STRAIGHT ROD, DUAL HEX
- TRANSVERSE CONNECTOR
- UNIPLANAR SCREW
- UNIPLANAR SCREW, EXTENDED TAB, FENESTRATED
- UNIPLANAR SCREW, EXTENDED TAB, TRANSVERSE, FENESTRATED
- UNIPLANAR SCREW, FENESTRATED TRANSVERSE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.