PMA P060037S038
- Device
- NEXGEN LPS-FLEX/ LPS MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S038
- Product code
- NJL
- Decision date
- 2015-10-06
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- APPROVAL FOR AUTOMATING THE FINAL CLEANING PROCESS FOR NEXGEN LPS-FLEX/LPS MOBILE BEARING KNEE SYSTEM COMPONENTS, AND INTRODUCING A NEW CLEANING DETERGENT FOR TIBIAL COMPONENTS.
Current openFDA PMA Record#
- Device
- NEXGEN LPS-FLEX/ LPS MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S038
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2015-10-06
- Decision code
- APPR
- Date received
- 2015-06-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AUTOMATING THE FINAL CLEANING PROCESS FOR NEXGEN LPS-FLEX/LPS MOBILE BEARING KNEE SYSTEM COMPONENTS, AND INTRODUCING A NEW CLEANING DETERGENT FOR TIBIAL COMPONENTS.