Medical device licence · 69321 · Class 2
ORTHOPEDIC BONE REAMERS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 20, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 69321
- Licence holder
- Exactech Inc.Gainesville, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 20, 2005
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EQUINOX REAMERS
- EQUINOXE SHOULDER MODULAR GLENOID REAMER HEAD ASSEMBLY
- EQUINOXE SHOULDER MODULAR PRIMARY REAMER PILOT TIP
- EQUINOXE SHOULDER NUBLESS GLENOID REAMER
- MODULAR ATSA REAMER
- MODULAR NARROW PRIMARY CANNULATED REAMER HEAD
- MODULAR NARROW PRIMARY PILOT-TIP REAMER HEAD
- MODULAR NARROW REVERSE SHOULDER CANNULATED REAMER HEAD
- MODULAR NARROW REVERSE SHOULDER PILOT REAMER HEAD
- MODULAR PRIMARY REAMER CANNULATED
- MODULAR PRIMARY REAMER PILOT TIP
- MODULAR REVERSE REAMER
- MODULAR REVERSE REAMER CANNULATED
- MODULAR REVERSE REAMER PILOT TIP
- MODULAR REVERSE REAMER STARTER, CANNULATED
- MODULAR REVERSE REAMER STARTER, PILOT TIP
- OPTETRAK PATELLAR REAMER
- OPTETRAK PATELLAR REAMER BLADE
- OPTETRAK STEM EXTENSION REAMER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.