Medical device licence · 79690 · Class 3
SPECTRA-SYSTEM FIXATION SCREWS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 6, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79690
- Licence holder
- Implant Direct Sybron Manufacturing LlcThousand Oaks, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- May 6, 2009
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FIXATION SCREW
- LONG FIXATION SCREW
- MULTI-UNIT ABUTMENT COPING SCREW
- REPLANT FIXATION SCREW
- SHORT FIXATION SCREW
- SPECTRA-SYSTEM FIXATION SCREW
- SWISH FIXATION SCREW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.