Medical device licence · 82280 · Class 3
ALLOFIT ALLOCLASSIC ACETABULAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 16, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82280
- Licence holder
- Zimmer Switzerland Manufacturing GmbhWinterthur, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 16, 2010
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALLOFIT -S IT ALLOCLASSIC ACETABULAR SHELL UNCEMENTED WITH POLAR SCREW PLUG
- ALLOFIT ALLOCLASSIC SCREW HOLE PLUG
- ALLOFIT IT ALLOCLASSIC ACETABULAR SHELL UNCEMENTED WITH POLAR SCREW PLUG
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 “allofit”. A notice may cover another product or only some lots: read it to see what it covers.
- CUSTOM TRILOGY STYLE ALLOFIT IT INSERTER (2015-11-24)January 14, 2016 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.