PMA P060037S069
- Device
- NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System
- Applicant
- ZIMMER, INC.
- PMA number
- P060037
- Supplement
- S069
- Product code
- NJLÂ
- Decision date
- 2020-12-21
- Generic name
- Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
- Approval order statement
- Approval For A Change To The Design And Materials Of The Device Packaging System For The Ultra-high Molecular Weight Polyethylene (UHMWPE) Tibial Articular Surface Components Of The NexGen LPS-Flex Mobile / LPS-Mobile Bearing Knee System And An Associated Change To The Product Shelf Life.
Current openFDA PMA Record
- Device
- NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System
- Applicant
- Zimmer, Inc.
- PMA number
- P060037
- Supplement
- S069
- Product code
- NJL
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2020-12-21
- Decision code
- APPR
- Date received
- 2020-09-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Change to the design and materials of the device packaging system for the ultra-high molecular weight polyethylene (UHMWPE) tibial articular surface components of the NexGen LPS-Flex Mobile / LPS-Mobile Bearing Knee System and an associated change to the product shelf life.