ApprovalTrail

Medical device licence · 101585 · Class 3

DOUBLE ENDOBUTTON FIXATION DEVICE

Yes: licensed in Canada

Licence status Issued (active); first licensed August 10, 2018. It is in Health Canada’s list of active licences.
Licence number
101585
Licence holder
Smith & Nephew, Inc. EndoscopyAndover, MA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
August 10, 2018
Devices covered
18

Devices on this licence

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

  • 10 DEG OFFSET DRILL GUIDE
  • CANNULA COVER
  • CANNULA TROCAR
  • CANNULA TUBE
  • CORACOID DRILLING GUIDE
  • CORACOID DRILLING OFFSET GUIDE
  • DRILL WITH SLEEVE
  • GLENOID DRILL GUIDE
  • HALF CANNULA
  • HALF CANNULA OBTURATOR
  • LOOP TIP GUIDEWIRE
  • OFFSET MEASUREMENT TOOL
  • RECIPROCATING SAW BLADE
  • ROUND ENDOBUTTON
  • ROUND ENDOBUTTON W SUTURE LOOP
  • ROUND ENDOBUTTON W/POST
  • STRAIGHT CUT RECIPROCATING RASP
  • SUTURE TENSIONER

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