PMA P060037S006
- Device
- ZIMMER NEXGEN LPS-FLEX MOBILE & LPS-MOBILE BEARING KNEE SYSTEMS
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S006
- Product code
- NJL
- Decision date
- 2009-02-13
- 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 AN ALTERNATE MANUFACTURING PROCESS FOR THE LPS FEMORAL COMPONENTS, AN ADDITIONAL CLEANING LINE, NEW GRINDING EQUIPMENT, AND AN ADDITIONAL INSPECTION STEP.
Current openFDA PMA Record#
- Device
- ZIMMER NEXGEN LPS-FLEX MOBILE & LPS-MOBILE BEARING KNEE SYSTEMS
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S006
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2009-02-13
- Decision code
- APPR
- Date received
- 2008-10-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS FOR THE LPS FEMORAL COMPONENTS, AN ADDITIONAL CLEANING LINE, NEW GRINDING EQUIPMENT, AND AN ADDITIONAL INSPECTION STEP.