Medical device licence · 95297 · Class 3
CHESAPEAKE STABILIZATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 22, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95297
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 22, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CHESAPEAKE STABLILIZATION SYS IMPLANT
- CHESAPEAKE STABLILIZATION SYS SCREW
- DRILL GUIDE INSERTER
- EXPANDABLE DRILL GUIDE
- LORDOTIC TRIAL
- SINGLE BARREL DRILL GUIDE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “chesapeake”. A notice may cover another product or only some lots: read it to see what it covers.
- Chesapeake Anterior Lumbar Removal Tool (2021-09-07)September 24, 2021 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.