ApprovalTrail

Medical device licence · 104091 · Class 2

ORTHO-FYX WIREFORMS - TITANIUM

Yes: licensed in Canada

Licence status Issued (active); first licensed December 26, 2019. It is in Health Canada’s list of active licences.
Licence number
104091
Licence holder
Phildent Canada Inc.Etobicoke, ON, Canada
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
December 26, 2019
Devices covered
17

Devices on this licence

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

  • ORTHO-FYX WIREFORMS NITI ARCHWIRE THERMAL BIOFORM 3
  • ORTHO-FYX WIREFORMS NITI ARCHWIRE TORQUED NATURAL FORM
  • ORTHO-FYX WIREFORMS NITI ARCHWIRE TRI-FORCE BIOFORM 3
  • ORTHO-FYX WIREFORMS NITI ARCHWIRE TRI-FORCE NATURAL FORM
  • ORTHO-FYX WIREFORMS NITI SE ARCHWIRE BIOFORM 3
  • ORTHO-FYX WIREFORMS NITI SE ARCHWIRE EUROPA I FORM
  • ORTHO-FYX WIREFORMS NITI SE ARCHWIRE NATURAL FORM
  • ORTHO-FYX WIREFORMS NITI SE ARCHWIRE REVERSE CURVE TYPE 1
  • ORTHO-FYX WIREFORMS NITI SE ARCHWIRE REVERSE CURVE TYPE 5
  • ORTHO-FYX WIREFORMS NITI SE ARCHWIRE STANDARD FORM
  • ORTHO-FYX WIREFORMS NITI SE ARCHWIRE TOOTH TONE BIOFORM 3
  • ORTHO-FYX WIREFORMS NITI SE ARCHWIRE TOOTH TONE EUROPA 1 FORM
  • ORTHO-FYX WIREFORMS NITI THERMAL ARCHWIRE EUROPA 1 FORM
  • ORTHO-FYX WIREFORMS NITI THERMAL ARCHWIRE NATURAL FORM
  • ORTHO-FYX WIREFORMS NITI THERMAL ARCHWIRE REVERSE CURVE TYPE 1
  • ORTHO-FYX WIREFORMS NITI THERMAL ARCHWIRE STANDARD FORM
  • ORTHO-FYX WIREFORMS NITI TOOTH TONE ARCHWIRE NATURAL FORM

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