PMA P060037S077
- Device
- NexGen® LPS-Flex / LPS-Mobile Bearing Knee
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S077
- Product code
- NJL
- Decision date
- 2022-02-10
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- For Relocation Of Some Manufacturing Steps And In-process Cleaning Steps For Fluted Mobile Stemable Tray Set Screw, Which Is A Sub-component Of NexGen LPS Mobile Knee Fluted Stem Mobile Knee Precoat Tibial Baseplate
Current openFDA PMA Record
- Device
- NexGen® LPS-Flex / LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S077
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2022-02-10
- Decision code
- OK30
- Date received
- 2022-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of some manufacturing steps and in-process cleaning steps for Fluted Mobile Stemable Tray Set Screw, which is a sub-component of NexGen LPS Mobile Knee Fluted Stem Mobile Knee Precoat Tibial Baseplate.