PMA P060037S049
- Device
- Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S049
- Product code
- NJL
- Decision date
- 2017-07-06
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- Addition of a second test method for performing Bacterial Endotoxin Testing (BET).
Current openFDA PMA Record#
- Device
- Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S049
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2017-07-06
- Decision code
- OK30
- Date received
- 2017-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a second test method for performing Bacterial Endotoxin Testing (BET).