PMA P830055S268
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- Product code
- NJL
- Decision date
- 2021-07-07
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Addition of an automated clean and passivation system (Miraclean) at the Lincotek Medical manufacturing facility.
Current openFDA PMA Record#
- Device
- LCS Total Knee System
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S268
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2021-07-07
- Decision code
- OK30
- Date received
- 2021-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an automated clean and passivation system (Miraclean) at the Lincotek Medical manufacturing facility.