PMA P060037S040
- Device
- ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S040
- Product code
- NJL
- Decision date
- 2015-10-27
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- TO ADD A NEW CONTRACT LABORATORY TO INCREASE BIOLOGICAL INDICATOR VERIFICATION TESTING CAPACITY FOR THE LPS MOBILE TIBIAL ARTICULAR SURFACE COMPONENTS.
Current openFDA PMA Record#
- Device
- ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S040
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2015-10-27
- Decision code
- OK30
- Date received
- 2015-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO ADD A NEW CONTRACT LABORATORY TO INCREASE BIOLOGICAL INDICATOR VERIFICATION TESTING CAPACITY FOR THE LPS MOBILE TIBIAL ARTICULAR SURFACE COMPONENTS.