Medical device licence · 2400 · Class 3
PFC SIGMA KNEE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 20, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 2400
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 20, 1999
- Devices covered
- 28
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PFC SIGMA KNEE SYSTEM - ALL POLYETHYLENE TIBIAL COMPONENTS CURVED
- PFC SIGMA KNEE SYSTEM - ALL POLYETHYLENE TIBIAL COMPONENTS POSTERIOR LIPPED
- PFC SIGMA KNEE SYSTEM - ALL-POLYETHYLENE TIBIAL COMPONENTS STABILIZED
- PFC SIGMA KNEE SYSTEM - CRUCIATE RETAINING FEMORAL NON-POROUS COATING
- PFC SIGMA KNEE SYSTEM - CRUCIATE SUBSTITUTING FEMORAL NON-POROUS COATING
- PFC SIGMA KNEE SYSTEM - CURVED RP BEARING
- PFC SIGMA KNEE SYSTEM - FEMORAL ADAPTER
- PFC SIGMA KNEE SYSTEM - FEMORAL ADAPTER BOLT
- PFC SIGMA KNEE SYSTEM - FEMORAL AUGMENTATION
- PFC SIGMA KNEE SYSTEM - FEMORAL BOLT
- PFC SIGMA KNEE SYSTEM - FEMORAL STEM COLLAR
- PFC SIGMA KNEE SYSTEM - M.B.T. CEMENTED KNEE TRAY
- PFC SIGMA KNEE SYSTEM - M.B.T. POROUS COATED KEEL TRAY
- PFC SIGMA KNEE SYSTEM - M.B.T. POROUS COATED TRAY
- PFC SIGMA KNEE SYSTEM - M.B.T. REVISION CEMENTED TRAY
- PFC SIGMA KNEE SYSTEM - MBT REVISION TIBIAL TRAY
- PFC SIGMA KNEE SYSTEM - MODULAR PLUS OFFSET TIBIAL TRAY
- PFC SIGMA KNEE SYSTEM - PATELLA
- PFC SIGMA KNEE SYSTEM - PS RP BEARING
- PFC SIGMA KNEE SYSTEM - RP TC3 TIBIAL INSERT
- PFC SIGMA KNEE SYSTEM - RPF CEMENTED FEMORAL COMPONENT
- PFC SIGMA KNEE SYSTEM - RPF TIBIAL INSERT
- PFC SIGMA KNEE SYSTEM - SIGMA TC3 FEMORAL NON-POROUS COATING
- PFC SIGMA KNEE SYSTEM - STABILIZED TIBIAL INSERT
- PFC SIGMA KNEE SYSTEM - TIBIAL CURVED INSERT
- PFC SIGMA KNEE SYSTEM - TIBIAL INSERT POSTERIOR LIPPED
- PFC SIGMA KNEE SYSTEM - TIBIAL INSERT TC3
- PFC SIGMA KNEE SYSTEM-M.B.T. CEMENTED TRAY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.