Medical device licence · 63243 · Class 3
ARTHREX FIBERWIRE BUTTON KITS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 14, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 63243
- Licence holder
- Arthrex IncNaples, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- November 14, 2003
- Devices covered
- 45
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACL REPAIR TIGHTROPE, ATTACHABLE BUTTON SYSTEM IMPLANT
- ACL REPAIR TIGHTROPE, WITH INTERNALBRACE LIGAMENT AUGMENTATION
- ACL TIGHTROPE BUTTON KIT
- ACL TIGHTROPE DOUBLE BUNDLE (DB) BUTTON KIT
- ACL TIGHTROPE II RT
- ACL TIGHTROPE II RT, DOUBLE LOADED PASSING SUTURES
- ACL TIGHTROPE II RT, WITH INTERNALBRACE LIGAMENT AUGMENTATION
- ACTIGHTROPE REPAIR KIT
- ARTHREX FIBERWIRE BUTTON KIT CONTENTS ONLY
- ARTHREX TWO-HOLE SYNDESMOSIS PLATE
- BTB TIGHTROPE II
- BTB TIGHTROPE II, DOUBLE LOADED PASSING SUTURES
- BTB TIGHTROPE II, WITH INTERNALBRACE LIGAMENT AUGMENTATION
- BUTTON, PEC REPAIR KIT
- DISTAL BICEPS BUTTON REPAIR KIT
- DISTAL CLAVICLE BUTTON, STAINLESS STEEL
- FIBERTAG TIGHTROPE II ABS IMPLANT WITH ATTACHED NEEDLE
- FIBERTAG TIGHTROPE II IMPLANT FOR THE INTERNALBRACE TECHNIQUE WITH ATTACHED NEEDLE
- FIBERTAG TIGHTROPE II IMPLANT WITH ATTACHED NEEDLE
- IMPLANT DELIVERY SYSTEM, PEC REPAIR BUTTON KIT
- IMPLANT SYSTEM, ACUTE AC REPAIR
- IMPLANT SYSTEM, CMC MINI TIGHTROPE
- IMPLANT SYSTEM, PROXIMAL TENODESIS BUTTON KIT
- IMPLANT SYSTEM, TIGHTROPE II RT-IB
- KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT
- KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT, FOR DISTAL CLAVICLE PLATE
- KNOTLESS AC TIGHTROPE REPAIR IMPLANT WITH DOG BONE BUTTON
- KNOTLESS AC TIGHTROPE REPAIR IMPLANT WITH DOG BONE BUTTON, FOR DISTAL CLAVICLE PLATE
- KNOTLESS AC TIGHTROPE REPAIR SYSTEM
- KNOTLESS MINI TIGHTROPE IMPLANT SYSTEM
- KNOTLESS TIGHTROPE SYNDESMOSIS, STAINLESS STEEL
- KNOTLESS TIGHTROPE SYNDESMOSIS, TITANIUM
- MINI TIGHTROPE FT REPAIR KIT
- MINI TIGHTROPE REPAIR KIT
- PROXIMAL TENODESIS BUTTON KIT
- QUADLINK IMPLANT SYSTEM WITH FIBERTAG
- RETROBUTTON
- SYNDESMOSIS TIGHTROPE XP BUTTRESS PLATE IMPLANT SYSTEM, SYNDESMOSIS 2 HOLE BUTTRESS PLATE
- TENODESIS BUTTON
- TIGHTROPE II ABS, IMPLANT
- TIGHTROPE II ABS, IMPLANT, OPEN
- TIGHTROPE SYNDESMOSIS REPAIR KIT
- TIGHTROPE, PCL BUTTON KIT
- TWIN TAIL AC TIGHTROPE BUTTON KIT
- TWO INCISION DISTAL BICEPS IMPLANT SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.