Medical device licence · 73406 · Class 3
ANATOMIC RADIAL HEAD SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 21, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 73406
- Licence holder
- Acumed, LlcHillsboro, OR, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 21, 2007
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANATOMIC RADIAL HEAD SYSTEM - BROACH ASSEMBLY
- ANATOMIC RADIAL HEAD SYSTEM - COLLAR REAMER
- ANATOMIC RADIAL HEAD SYSTEM - HEAD IMPACTOR
- ANATOMIC RADIAL HEAD SYSTEM - HEAD, LEFT
- ANATOMIC RADIAL HEAD SYSTEM - HEAD, RIGHT
- ANATOMIC RADIAL HEAD SYSTEM - HEIGHT GAGE
- ANATOMIC RADIAL HEAD SYSTEM - IMPACTOR BASE
- ANATOMIC RADIAL HEAD SYSTEM - QUICK RELEASE AWL
- ANATOMIC RADIAL HEAD SYSTEM - QUICK RELEASE T-HANDLE
- ANATOMIC RADIAL HEAD SYSTEM - STEM
- ANATOMIC RADIAL HEAD SYSTEM - STEM GAGE ASSEMBLY
- ANATOMIC RADIAL HEAD SYSTEM - STEM REMOVAL TOOL
- ANATOMIC RADIAL HEAD SYSTEM - TRIAL GAGE
- ANATOMIC RADIAL HEAD SYSTEM - TRIAL HEAD, LEFT
- ANATOMIC RADIAL HEAD SYSTEM - TRIAL HEAD, RIGHT
- ANATOMIC RADIAL HEAD SYSTEM - TRIAL STEM
- ARH REMOVAL TOOL SHAFT
- CROSS BAR
- LONG STEM REAMER
- LONG STEM RESECTION GUIDE
- MORSE TAPER LONG STEM
- MORSE TAPER LONG STEM ALIGNMENT GUIDE
- RADIUS RETRACTOR
- STANDARD STEM REAMER
- TRIAL MORSE TAPER LONG STEM, LEFT
- TRIAL MORSE TAPER LONG STEM, RIGHT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.