Medical device licence · 92397 · Class 3
ACUMED LOCKING SCAPULA PLATE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 5, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92397
- Licence holder
- Acumed, LlcHillsboro, OR, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 5, 2013
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLAVICLE RETRACTOR
- CORTICAL SCREW
- DEPTH PROBE
- FLEXIBLE HEX DRIVER
- LAG GUIDE
- LOCKING DRILL GUIDE
- PLATE CLAMP
- QUICK RELEASE HANDLE
- SCAPULA MEDICAL BORDER PLATE TRIAL
- SCAPULA ACROMION PLATE
- SCAPULA ACROMION PLATE TRIAL
- SCAPULA GLENOID PLATE
- SCAPULA GLENOID PLATE TRIAL
- SCAPULA LATERAL BORDER PLATE
- SCAPULA LATERAL BORDER PLATE TRIAL
- SCAPULA MEDIAL BORDER PLATE
- SOLID, QUICK RELEASE, DRIVER TIP
- UNIVERSAL TRAY SCREW INSERT ASSEMBLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.