ApprovalTrail

Medical device licence · 102361 · Class 3

EQUINOXE STEMLESS SHOULDER

Yes: licensed in Canada

Licence status Issued (active); first licensed February 11, 2019. It is in Health Canada’s list of active licences.
Licence number
102361
Licence holder
Exactech Inc.Gainesville, FL, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 11, 2019
Devices covered
13

Devices on this licence

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

  • CALCAR PLANER BLADE
  • EQUINOXE STEMLESS HUMERAL CAGE
  • EQUINOXE STEMLESS HUMERAL HEAD
  • HUMERAL PROTECTOR
  • STEINMANN PIN
  • STEMLESS HUMERAL DRILL
  • STEMLESS HUMERAL TAMP
  • STEMLESS PUNCH INSERTER
  • STEMLESS REVISION PUNCH
  • STEMLESS SIZING GUIDE
  • STEMLESS SIZING GUIDE HANDLE
  • STEMLESS SPRING INSERTER
  • TRIAL STEMLESS HUMERAL HEAD

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “equinoxe”. A notice may cover another product or only some lots: read it to see what it covers.

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