Medical device licence · 110534 · Class 3
LEOS PLATING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 6, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110534
- Licence holder
- Tyber Medical, Llc.Bethlehem, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 6, 2023
- Devices covered
- 32
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LEOS CARTILAGE REMOVAL TOOL
- LEOS COMPRESSION DRILL GUIDE
- LEOS DRILL
- LEOS K-WIRE
- LEOS L-SHAPE PLATE
- LEOS LAG DRILL
- LEOS LAPIDUS
- LEOS LAPIDUS REVISION
- LEOS LAPIDUS TARGETING GUIDE IMC
- LEOS LAPIDUS TARGETING GUIDE MED
- LEOS LOCKING DRILL GUIDE
- LEOS LOCKING SCREW
- LEOS MTP FEMALE REAMER
- LEOS MTP MALE REAMER
- LEOS MTP PLATE
- LEOS MTP REVISION PLATE
- LEOS MTP TARGETING GUIDE
- LEOS NON-LOCKING SCREW
- LEOS PLATE TACK
- LEOS RETENTION DRIVER
- LEOS SMOOTH K-WIRE
- LEOS STRAIGHT PLATE
- LEOS SUBCHONDRAL DRILL
- LEOS T-SHAPE PLATE
- LEOS TARGETING GUIDE ATTACHMENT BOLT
- LEOS TARGETING GUIDE WIRE SLEEVE
- LEOS THREADED K-WIRE
- LEOS TMT 1ST-2ND PLATE
- LEOS TMT 2ND-3RD PLATE
- LEOS VARIABLE AND FIXED DRILL GUIDE
- LEOS X-PLATE
- LEOS Y-SHAPE PLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.