ApprovalTrail

Medical device licence · 104415 · Class 2

STERILE DRILLS

Yes: licensed in Canada

Licence status Issued (active); first licensed March 5, 2020. It is in Health Canada’s list of active licences.
Licence number
104415
Licence holder
Arthrex IncNaples, FL, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
March 5, 2020
Devices covered
33

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • CHONDRALDRILL, HIP, DRILL BIT (STERILE)
  • DISPOSABLE DRILL FOR HIP FIBERTAK SUTURE ANCHOR (STERILE)
  • DISPOSABLE DRILL, HARD BONE, FOR HIP PUSHLOCK (STERILE)
  • DISPOSABLE FLEXIBLE FLUTED DRILL, FOR KNOTLESS HIP FIBERTAK SUTURE ANCHOR
  • DISPOSABLES KIT, FOR PUSHLOCK WITH DRILL AND OFFSET SPEAR (STERILE)
  • DRILL BIT (STERILE)
  • DRILL FOR MINI BIO-ANCHOR (STERILE)
  • DRILL FOR PUSHLOCK (STERILE)
  • DRILL FOR PUSHLOCK ANCHOR, HARD BONE (STERILE)
  • DRILL FOR SWIVELOCK (STERILE)
  • DRILL, CANNULATED (STERILE)
  • DRILL, CANNULATED, FOR AC REPAIR (STERILE)
  • DRILL, FOR FIBERTAK (STERILE)
  • DRILL, FOR KNOTLESS HIP FIBERTAK SUTURE ANCHOR
  • DRILL, FOR PUSHLOCK, HARD BONE (STERILE)
  • DRILL, FOR PUSHLOCK, HARD BONE (STERILE)
  • DRILL, KNOTLESS CORKSCREW (STERILE)
  • DRILL, SPADE TIP, SWIVELOCK ANCHOR (STERILE)
  • DUAL RETROCUTTER (STERILE)
  • FLEXIBLE DRILL FOR 2.4 MM KNOTLESS HIP SUTURETAK
  • FLIPCUTTER II
  • IBALANCE UKA FIXATION PIN (STERILE)
  • KNEE FIBERTAK DRILL
  • POWERPICK INSTRUMENT (STERILE)
  • RETROBUTTON DRILL PIN II (STERILE)
  • RETROCUTTER (STERILE)
  • SHAVERDRILL FOR KNOTLESS SUTURETAK, HARD BONE (STERILE)
  • SHAVERDRILL FOR PUSHLOCK
  • SHAVERDRILL FOR PUSHLOCK ANCHOR, HARD BONE (STERILE)
  • SHAVERDRILL PUSHLOCK (STERILE)
  • SHAVERDRILL SUTURETAK (STERILE)
  • STEP DRILL, KNOTLESS SUTURETAK (STERILE)
  • STEP DRILL, KNOTLESS SUTURETAK, HARD BONE (STERILE)

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.