Medical device licence · 15205 · Class 3
OMEGA 21 SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed December 14, 1999; ended November 5, 2009. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 15205
- Licence holder
- Ebi, LlcParsippany, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 14, 1999
- Ended
- November 5, 2009
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OMEGA 21 SYSTEM - ACCESSORIES
- OMEGA 21 SYSTEM - COUPLERS/CONNECTORS
- OMEGA 21 SYSTEM - EXPANSIVE SCREWS
- OMEGA 21 SYSTEM - HOOK, LAMINAR
- OMEGA 21 SYSTEM - HOOK, PEDICLE
- OMEGA 21 SYSTEM - LOCKING NUT
- OMEGA 21 SYSTEM - RODS
- OMEGA 21 SYSTEM - SELFTAPPING SCREWS
- OMEGA 21 SYSTEM - SPONDYLISTHESIS SELFTAPPING SCREWS
- OMEGA 21 SYSTEM - TRANSVERSE ROD CONNECTOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.