PMA P060037S076
- Device
- NexGen® LPS-Flex / LPS-Mobile Bearing Knee
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S076
- Product code
- NJL
- Decision date
- 2022-01-05
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- Reduction In The Number Of Biological Indicators (BIs) For Performance Requalification And Routine Monitoring For Hydrogen Peroxide (VHP) Gas Plasma Sterilization Of Their Subject Device, NexGen® LPS Flex/LPS Mobile Bearing Knee System, Cross-linked Polyethylene Prolong Articular Surface
Current openFDA PMA Record
- Device
- NexGen® LPS-Flex / LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S076
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2022-01-05
- Decision code
- OK30
- Date received
- 2021-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in the number of biological indicators (BIs) for performance requalification and routine monitoring for hydrogen peroxide (VHP) gas plasma sterilization of their subject device, NexGen® LPS Flex/LPS Mobile Bearing Knee System, Cross-linked Polyethylene Prolong Articular Surface.