PMA P060037S061
- Device
- Nexgen LPS-Flex/LPS-Mobile Bearing Knee
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S061
- Product code
- NJL
- Decision date
- 2019-08-07
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- Removal Of The Cytotoxicity Test Requirement From The Routine Process Monitoring Of The Final Cleaning Process For The NexGen®Complete Knee Solution, Legacy® Knee – Posterior Stabilized (LPS) And The LPS-Flex Mobile Bearing Knee Femoral Components, At The Shannon, Ireland Facility
Current openFDA PMA Record
- Device
- Nexgen LPS-Flex/LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S061
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2019-08-07
- Decision code
- OK30
- Date received
- 2019-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the cytotoxicity test requirement from the routine process monitoring of the final cleaning process for the NexGen®Complete Knee Solution, Legacy® Knee Posterior Stabilized (LPS) and the LPS-Flex Mobile Bearing Knee femoral components, at the Shannon, Ireland facility.