Medical device licence · 12225 · Class 3
ACUTRAK PLUS FIXATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 21, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 12225
- Licence holder
- Acumed, LlcHillsboro, OR, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 21, 1999
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACUTRAK PLUS BONE SCREW SYSTEM
- ACUTRAK PLUS FIXATION SYSTEM - DENSE BONE DRILL
- ACUTRAK PLUS FIXATION SYSTEM - DRILL
- ACUTRAK PLUS FIXATION SYSTEM - FIXATION SCREW
- ACUTRAK PLUS FIXATION SYSTEM - PROBE
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 “acutrak”. A notice may cover another product or only some lots: read it to see what it covers.
- 24.0mm, 35.0mm, And 45.0 Mm Acutrak 2 4.7 ScrewsJanuary 29, 2025 · Orthopaedics · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.