Medical device licence · 86220 · Class 2
IMPACTORS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 27, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86220
- Licence holder
- Mako Surgical Corp.Weston, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 27, 2011
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CUP IMPACTION PLATFORM
- RESTORIS MCK FEMORAL IMPACTOR
- RESTORIS MCK INLAY/BASEPLATE IMPACTOR
- RESTORIS MCK ONLAY INSERT IMPACTOR
- RESTORIS MCK PATELLOFEMORAL IMPACTOR
- STRAIGHT CUP IMPACTOR
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 “impactors”. A notice may cover another product or only some lots: read it to see what it covers.
- Standard Offset Cup Impactors (2014-03-28)September 9, 2014 · Medical devices · Medical devices · Type II
- Tornier Aequalis Reversed Impactors (2013-08-13)December 17, 2013 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.