PMA P830055S226
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S226
- Product code
- NJL
- Decision date
- 2019-05-09
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Approval for a manufacturing site located at Drayton Fields Industrial Estate Brunel Close, Daventry Northamptonshire, United Kingdom NN11 8RB for sterilization by gamma radiation of system components.
Current openFDA PMA Record#
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S226
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-05-09
- Decision code
- APPR
- Date received
- 2019-03-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Drayton Fields Industrial Estate Brunel Close, Daventry Northamptonshire, United Kingdom NN11 8RB for sterilization by gamma radiation of system components.