PMA P060037S068
- Device
- NexGen LPS-Flex and LPS Mobile Bearing Knee System
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S068
- Product code
- NJLÂ
- Decision date
- 2020-09-25
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- Addition Of A New Furnace Equipment For The Hot Isostatic Pressing (HIP) Process In The Casting Process For The NexGen Femoral Components
Current openFDA PMA Record
- Device
- NexGen LPS-Flex and LPS Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S068
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2020-09-25
- Decision code
- OK30
- Date received
- 2020-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new furnace equipment for the Hot Isostatic Pressing (HIP) process in the casting process for the NexGen Femoral components.