PMA P060037S050
- Device
- Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S050
- Product code
- NJL
- Decision date
- 2017-09-29
- Classification
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Approval order statement
- New and modified heat seal parameters, which define the process parameters for the heat sealing of sterile package lidding to thermoformed polymer trays as part of the packaging configuration for NexGen LPS-Flex/LPS-Mobile Bearing Knee System tibial bearing components.
Current openFDA PMA Record#
- Device
- Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S050
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2017-09-29
- Decision code
- OK30
- Date received
- 2017-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New and modified heat seal parameters, which define the process parameters for the heat sealing of sterile package lidding to thermoformed polymer trays as part of the packaging configuration for NexGen LPS-Flex/LPS-Mobile Bearing Knee System tibial bearing components.