PMA P830055S342
- Device
- LCS(R) TOTAL KNEE SYSTEM
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S342
- Product code
- NJL
- Decision date
- 2025-04-10
- Classification
- Orthopedic
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- a cleaning process change for manufacturing components of the LCS Total Knee System in the Suzhou, China facility
Current openFDA PMA Record#
- Device
- LCS(R) TOTAL KNEE SYSTEM
- Applicant
- Depuy, Inc.
- PMA number
- P830055
- Supplement
- S342
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2025-04-10
- Decision code
- OK30
- Date received
- 2025-04-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a cleaning process change for manufacturing components of the LCS Total Knee System in the Suzhou, China facility