Medical device licence · 113008 · Class 3
CRANIOXPAND
Yes: licensed in Canada
Licence status Issued (active); first licensed April 2, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113008
- Licence holder
- Kls Martin L.P.Jacksonville, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 2, 2025
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISTRACTION, INTERNAL, INSERTER, SPRING, CRANIOXPAND, BACKWARD OPENING
- DISTRACTION, INTERNAL, INSERTER, SPRING, CRANIOXPAND, FORWARD OPENING
- DISTRACTION, INTERNAL, SELECTOR, SPRING, CRANIOXPAND
- DISTRACTION, INTERNAL, STERILE, SPRING, CRANIOXPAND, STAINLESS STEEL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.