Medical device licence · 76569 · Class 3
ARTIFICIAL LIGAMENT FIXATION DEVICE - TOGGLE LOC
Yes: licensed in Canada
Licence status Issued (active); first licensed March 14, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76569
- Licence holder
- Biomet Orthopedics, Ata Biomet Sports Medicine, Ata Biomet Biologics, Ata Biomet TraumaWarsaw, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 14, 2008
- Devices covered
- 17
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ARTIFICIAL LIGAMENT FIXATION DEVICE BTB TOGGLELOC EXT ZIPLOOP TI ALLOY/POLY
- ARTIFICIAL LIGAMENT FIXATION DEVICE TO NS TOGGLELOC W/ MAXBRAIDE LOOP
- ARTIFICIAL LIGAMENT FIXATION DEVICE ZIPLOOP EXT. TOGGLELOC TI ALLOY POLY.
- TOGGLELOC 2.9MM WITH NEEDLES, #2 MAXBRAID
- TOGGLELOC 2.9MM, #2 MAXBRAID
- TOGGLELOC INLINE DISPOSABLE KIT, FIXATION DEVICE W/ ZIPLOOP TECHNOLOGY IMPLANT KIT
- TOGGLELOC PUSHER
- TOGGLELOC WITH ZIPLOOP INLINE, FIXATION DEVICE
- TOGGLELOC WITH ZIPLOOP, BTB IMPLANT KIT
- TOGGLELOC WITH ZIPLOOP, ELBOW IMPLANT
- TOGGLELOC WITH ZIPLOOP, ELBOW IMPLANT KIT
- TOGGLELOC WITH ZIPLOOP, ELBOW IMPLANT KIT WITH CANNULA
- TOGGLELOC WITH ZIPLOOP, FIXATION DEVICE
- TOGGLELOC WITH ZIPLOOP, STANDARD ZIPLOOP IMPLANT KIT
- TOGGLELOC XL WITH ZIPLOOP INLINE, FIXATION DEVICE
- TOGGLELOC XL WITH ZIPLOOP, FIXATION DEVICE
- TOGGLELOC/WASHERLOC DISP KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.