Medical device licence · 106269 · Class 2
NIAGARA LATERAL ACCESS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 15, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106269
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 15, 2021
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NIAGARA LATERAL ACCESS SYSTEM BLADE PIN SHIM
- NIAGARA LATERAL ACCESS SYSTEM CROSS HAIR
- NIAGARA LATERAL ACCESS SYSTEM DRIVER (SHORT)
- NIAGARA LATERAL ACCESS SYSTEM EXTENDED DRIVER
- NIAGARA LATERAL ACCESS SYSTEM GUIDEWIRE PACK
- NIAGARA LATERAL ACCESS SYSTEM INTRADISCAL SHIM
- NIAGARA LATERAL ACCESS SYSTEM LENGTHENING SHIM
- NIAGARA LATERAL ACCESS SYSTEM SHIM ADJUSTER
- NIAGARA LATERAL ACCESS SYSTEM SHIM PUSHER
- NIAGARA LATERAL ACCESS SYSTEM WIDENING SHIM (L)
- NIAGARA LATERAL ACCESS SYSTEM WIDENING SHIM (R)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.