PMA P060037S065
- Device
- NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S065
- Product code
- NJLÂ
- Decision date
- 2020-07-13
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- Approval For A Change In The Gamma Sterilization Process Monitoring For Conventional Ultra-high Weight Polyethylene (UHMWPE) Articular Surface Components In NexGen LPS-Flex/LPS Mobile Bearing Knee System.
Current openFDA PMA Record
- Device
- NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S065
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2020-07-13
- Decision code
- OK30
- Date received
- 2020-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the gamma sterilization process monitoring for conventional ultra-high weight polyethylene (UHMWPE) articular surface components in NexGen LPS-Flex/LPS Mobile Bearing Knee System.