PMA P060037S054
- Device
- NexGen LPS-Flex / LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S054
- Product code
- NJL
- Decision date
- 2018-03-05
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Addition of a new curing oven and its associated process parameter specifications that is used during the PMMA coating process for NexGen® Complete Knee Solution, Legacy® Knee Posterior Stabilized (LPS), LPS-Flex Mobile Bearing Knee, pre-coated femoral components.
Current openFDA PMA Record#
- Device
- NexGen LPS-Flex / LPS-Mobile Bearing Knee
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S054
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2018-03-05
- Decision code
- OK30
- Date received
- 2018-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new curing oven and its associated process parameter specifications that is used during the PMMA coating process for NexGen® Complete Knee Solution, Legacy® Knee Posterior Stabilized (LPS), LPS-Flex Mobile Bearing Knee, pre-coated femoral components.