Medical device licence · 105782 · Class 3
FIBERSTITCH IMPLANT
Yes: licensed in Canada
Licence status Issued (active); first licensed January 27, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105782
- Licence holder
- Arthrex IncNaples, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- January 27, 2021
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FIBERSTITCH IMPLANT 1.5, 24° CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, CURVED (RC) WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, REVERSE CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, STRAIGHT (RC) WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT 1.5, STRAIGHT WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT, 24 DEGREE CURVE WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT, CURVED WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT, REVERSE CURVE WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
- FIBERSTITCH IMPLANT, STRAIGHT WITH TWO POLYESTER IMPLANTS AND 2-0 FIBERWIRE SUTURE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.