ApprovalTrail

Medical device licence · 97974 · Class 2

OSTEOCOOL BONE ACCESS KIT

Yes: licensed in Canada

Licence status Issued (active); first licensed November 7, 2016. It is in Health Canada’s list of active licences.
Licence number
97974
Licence holder
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
November 7, 2016
Devices covered
4

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • OSTEOCOOL KIT BONE ACCESS 10G 090
  • OSTEOCOOL KIT BONE ACCESS 10G 095
  • OSTEOCOOL KIT BONE ACCESS 13G 100
  • OSTEOCOOL KIT BONE ACCESS 8G 090

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.