Medical device licence · 101169 · Class 2
INSIGHT LATERAL ACCESS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 5, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101169
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 5, 2018
- Devices covered
- 28
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 4TH BLADE CURVED NARROW
- 4TH BLADE CURVED WIDE
- 4TH BLADE STRAIGHT
- ADAPTER FOR RIGID ARM
- BLADE
- BLADE EXTENSION
- BLADE HOLDER
- BONE SCREW FOR BLADE FIXATION
- CONNECTOR FOR YOKE
- DILATOR ECCENTRIC
- DISC ANCHOR BLADE FOR 3RD BLADE HOLDER
- DISPOSABLE LIGHT-STERILE FOR LATERAL RETRACTOR
- ECCENTRIC DILATOR FOR LATERAL RETRACTOR
- FIXATION CLAMP FOR 4TH BLADES
- INNER SHAFT FOR DISC ANCHOR INSTRUMENT
- INSTRUMENT FOR BONE ANCHOR/WINGLETS AND BLADE EXTENSION
- INSTRUMENT FOR DISC ANCHOR
- KNOB FOR DISC ANCHOR INSTRUMENT
- RETRACTOR BODY
- SCOOP
- SCREWDRIVER
- SCREWDRIVER FOR BONE SCREW FOR BLADE FIXATION
- STRONG ARM
- STRONG ARM CONNECTOR
- STYLET
- TARGETING DEVICE
- WINGLET RIGHT
- YOKE FOR 4TH BLADE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.