Medical device licence · 80589 · Class 3
PEEK INTERFERENCE SCREWS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 2, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80589
- Licence holder
- Smith & Nephew, Inc. EndoscopyAndover, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- September 2, 2009
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BICEPTOR BIOSURE PK SCREW, 7 MM
- BICEPTOR BIOSURE PK SCREW, 8 MM
- BICEPTOR BIOSURE PK SCREW, 9 MM
- BIOSURE PK SCREW, 10 MM
- BIOSURE PK SCREW, 11 MM
- BIOSURE PK SCREW, 12 MM
- BIOSURE PK SCREW, 6 MM
- BIOSURE PK SCREW, 6 MM REVERSE
- BIOSURE PK SCREW, 7 MM
- BIOSURE PK SCREW, 7 MM REVERSE
- BIOSURE PK SCREW, 8 MM
- BIOSURE PK SCREW, 8 MM REVERSE
- BIOSURE PK SCREW, 9 MM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.