ApprovalTrail

Medical device licence · 105695 · Class 3

EQUINOXE PRESERVE STEM

Yes: licensed in Canada

Licence status Issued (active); first licensed January 11, 2021. It is in Health Canada’s list of active licences.
Licence number
105695
Licence holder
Exactech Inc.Gainesville, FL, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
January 11, 2021
Devices covered
6

Devices on this licence

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

  • BROACH, PRESERVE STEM
  • EQUINOXE PRESERVE HUMERAL STEM PRESS-FIT, PLASMA COATED
  • EXTENDED BROACH, PRESERVE STEM
  • REVERSE TRAY BROACH ADAPTER
  • STEM INSERTER/EXTRACTOR PRIMARY
  • TRIAL, HUMERAL ADAPTER TRAY

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.