Medical device licence · 91651 · Class 2
TERRA NOVA MI ACCESS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 12, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91651
- Licence holder
- K2M, Inc.Leesburg, VA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 12, 2013
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TERRA NOVA MI ACCESS SYSTEM - ANGLE BLADE
- TERRA NOVA MI ACCESS SYSTEM - BLADE HANDLE INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - CURETTE INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - HOOK RETRACTOR INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - LARGE RETRACTOR DISTRACTOR INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - MEDIUM RETRACTOR DISTRACTOR INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - MI ANGLED COMPRESSOR INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - MI ANGLED DISTRACTOR INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - MI DEPTH GAGE INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - RETRACTOR BLADE HOLDER INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - RETRACTOR DISTRACTOR RELEASE TOOL INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - RETRACTOR FRAME INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - SIDE LOADING TRANSVERSE RETRACTOR FRAME INSTRUMENT
- TERRA NOVA MI ACCESS SYSTEM - SMALL RETRACTOR DISTRACTOR INSTRUMENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.