PMA P060037S048
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S048
- Product code
- NJL
- Decision date
- 2017-01-12
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Introduce an alternative manufacturing material (i.e., liquid penetrant) that is used during the Liquid Penetrant Inspection process of the NexGen Complete Knee Solution, Legacy Knee – Posterior Stabilized (LPS), LPS-Flex Mobile Bearing Knee metal femoral components at the Shannon Ireland facility.
Current openFDA PMA Record#
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S048
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2017-01-12
- Decision code
- OK30
- Date received
- 2016-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce an alternative manufacturing material (i.e., liquid penetrant) that is used during the Liquid Penetrant Inspection process of the NexGen Complete Knee Solution, Legacy Knee – Posterior Stabilized (LPS), LPS-Flex Mobile Bearing Knee metal femoral components at the Shannon Ireland facility.