PMA P060037S094
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S094
- Product code
- NJL
- Decision date
- 2025-04-01
- Classification
- Orthopedic
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- a change to in-process cleaning carried out at the Warsaw, Indiana facility
Current openFDA PMA Record#
- Device
- NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S094
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2025-04-01
- Decision code
- OK30
- Date received
- 2025-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to in-process cleaning carried out at the Warsaw, Indiana facility