Medical device licence · 73697 · Class 3
EXPLOR ELBOW SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 2, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 73697
- Licence holder
- Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet TraumaWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 2, 2007
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXPLOR ELBOW SYSTEM - IMPLANT HEAD
- EXPLOR ELBOW SYSTEM - IMPLANT LOCKING SCREW
- EXPLOR ELBOW SYSTEM - IMPLANT STEM
- EXPLOR PROVISIONAL LOCKING SCREW
- EXPLOR TRIAL HEAD
- EXPLOR TRIAL STEM
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 “explor”. A notice may cover another product or only some lots: read it to see what it covers.
- Explor Modular Radial Stem With ScrewJuly 17, 2017 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.