Medical device licence · 70476 · Class 3
OPTETRAK TOTAL KNEE SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed February 15, 2006; ended October 31, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 70476
- Licence holder
- Exactech Inc.Gainesville, FL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 15, 2006
- Ended
- October 31, 2019
- Devices covered
- 29
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTETRAK TOTAL KNEE SYSTEM - CANCELLOUS BONE SCREWS
- OPTETRAK TOTAL KNEE SYSTEM - CC FEM STEM TAPER ADAPTERS FEM STEM SCREW INCL
- OPTETRAK TOTAL KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAYS
- OPTETRAK TOTAL KNEE SYSTEM - CEMENTED TRAPEZOID TIBIAL TRAYS
- OPTETRAK TOTAL KNEE SYSTEM - CEMENTED TRAPEZOID TIBIAL TRAYS
- OPTETRAK TOTAL KNEE SYSTEM - CONST COND. TIBIAL INSERTS W/SPINE STIFF SCREW
- OPTETRAK TOTAL KNEE SYSTEM - CONSTRAINED CONDYLAR CEMENTED FEMORAL COMP.
- OPTETRAK TOTAL KNEE SYSTEM - CRUCIATE RETAIN. POR-COATED FEMORAL COMPONENTS
- OPTETRAK TOTAL KNEE SYSTEM - CRUCIATE RETAINING ALL POLYETHYLENE TIBIAL COM
- OPTETRAK TOTAL KNEE SYSTEM - CRUCIATE RETAINING CEMENTED FEMORAL COMPONENTS
- OPTETRAK TOTAL KNEE SYSTEM - CRUCIATE RETAINING TIBIAL INSERTS
- OPTETRAK TOTAL KNEE SYSTEM - DISTAL FEMORAL AUGMENTATION BLOCKS
- OPTETRAK TOTAL KNEE SYSTEM - FEMORAL AUGMENTATION STACKING SCREWS
- OPTETRAK TOTAL KNEE SYSTEM - FLUTED STEM EXTENSIONS
- OPTETRAK TOTAL KNEE SYSTEM - HOLDING PINS
- OPTETRAK TOTAL KNEE SYSTEM - INSET PATELLA COMPONENTS
- OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL BACK TIBIAL COMP POST STAB FINNED
- OPTETRAK TOTAL KNEE SYSTEM - NON-MODULAR CONSTRAINED FEMORAL COMPONENTS
- OPTETRAK TOTAL KNEE SYSTEM - OFFSET TIBIAL TRAYS
- OPTETRAK TOTAL KNEE SYSTEM - ONE-PEG PATELLA COMPONENTS
- OPTETRAK TOTAL KNEE SYSTEM - POROUS FINNED TIBIAL TRAYS
- OPTETRAK TOTAL KNEE SYSTEM - POST. STABILIZED ALL POLYETHYLENE TIBIAL COMP.
- OPTETRAK TOTAL KNEE SYSTEM - POSTERIOR FEMORAL AUGMENTATION BLOCKS
- OPTETRAK TOTAL KNEE SYSTEM - POSTERIOR STABILIZED CEMENTED FEM COMPONENTS
- OPTETRAK TOTAL KNEE SYSTEM - POSTERIOR STABILIZED POR-COATED FEM COMPONENTS
- OPTETRAK TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
- OPTETRAK TOTAL KNEE SYSTEM - THREE-PEG PATELLA COMPONENTS
- OPTETRAK TOTAL KNEE SYSTEM - TIBIAL AUGMENTATION BLOCKS, 1/2 BLOCKS
- OPTETRAK TOTAL KNEE SYSTEM - TIBIAL AUGMENTATION BLOCKS, 1/3 BLOCKS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.