Medical device licence · 75907 · Class 3
SUTURE ANCHORS - PK
Yes: licensed in Canada
Licence status Issued (active); first licensed December 17, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 75907
- Licence holder
- Smith & Nephew, Inc. EndoscopyAndover, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- December 17, 2007
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIORAPTOR 2.3 PK SUTURE ANCHOR W/ULTRABRAID SUTURE
- BIORAPTOR 2.3 PK SUTURE ANCHOR WITH ULTRABRAID COBRAID SUTURE AND NEEDLES
- BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR
- BIORAPTOR KNOTLESS SUTURE ANCHOR
- BIORAPTOR KNOTLESS SUTURE ANCHOR, HIP
- DYNOMITE 20 PK W/NEEDLES AND ONE #2-0 ULTRABRAID WHITE
- FOOTPRINT MINI PK
- FOOTPRINT ULTRA PK SUTURE ANCHOR
- FOOTPRINT ULTRA PK SUTURE ANCHOR, SL
- HEALICOIL KNOTLESS PK SUTURE ANCHOR
- HEALICOIL PK 4.5MM SUTURE ANCHOR WITH TWO ULTRABRAID (BLUE/COBRAID BLUE)
- HEALICOIL PK 5.5MM SUTURE ANCHOR WITH THREE ULTRABRAID (BLUE/COBRAID BLUE/COBRAID BLACK)
- HEALICOIL PK 5.5MM SUTURE ANCHOR WITH TWO ULTRABRAID (BLUE/COBRAID BLUE)
- HEALICOIL PK SUTURE ANCHOR WITH NEEDLES, ULTRATAPE
- HEALICOIL PK SUTURE ANCHOR WITH ONE ULTRATAPE
- HEALICOIL PK SUTURE ANCHOR WITH ONE ULTRATAPE AND ONE ULTRABRAID SUTURE
- HEALICOIL PK SUTURE ANCHOR WITH THREE MINITAPE SUTURES
- HEALICOIL PK SUTURE ANCHOR WITH TWO MINITAPE SUTURES
- MICRORAPTOR KNOTLESS PEEK SUTURE ANCHOR
- RAPTORMITE 3.0 PK W/NEEDLES AND TWO #0 ULTRABRAID, WHITE AND COBRAID BLUE
- SPYROMITE 2.0 PK W/NEEDLES AND ONE #2-0 ULTRABRAID WHITE
- TWINFIX ULTRA PK 4.5 MM SUTURE ANCHOR W/TWO ULTRABRAID (#2) SUTURES
- TWINFIX ULTRA PK 5.5 MM SUTURE ANCHOR W/THREE ULTRABRAID (#2) SUTURES
- TWINFIX ULTRA PK 5.5 MM SUTURE ANCHOR W/TWO ULTRABRAID (#2) SUTURES
- TWINFIX ULTRA PK 6.5 MM SUTURE ANCHOR W/THREE ULTRABRAID (#2) SUTURES
- TWINFIX ULTRA PK 6.5 MM SUTURE ANCHOR W/TWO ULTRABRAID (#2) SUTURES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.