Medical device licence · 13320 · Class 3
SPECTRON HIP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 20, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 13320
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 20, 1999
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPECTROM EF HIP STEMS - 12-14 TAPER STEM FEMORAL COMPONENT
- SPECTRON EF HIP STEMS - 12-14 TAPER HIGH OFFSET FEMORAL COMPONENT
- SPECTRON EF REVISION LONG HIP STEM - 12/14 TAPER FEMORAL COMPONENT
- SPECTRON HIP SYSTEM - EF BROACH/TRIAL
- SPECTRON HIP SYSTEM - EF NECK REPLACEMENT BROACH/TRIAL
- SPECTRON HIP SYSTEM - EF REVISION NECK REPLACEMENT BROACH/TRIAL
- SPECTRON HIP SYSTEM - EF TRIAL NECK
- SPECTRON HIP SYSTEM - EF TRIAL NECK OFFSET
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 “spectron”. A notice may cover another product or only some lots: read it to see what it covers.
- Spectron EF Calibrated Guide Rod, Buck PlugJune 18, 2013 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.