PMA P060037S079

Device: NexGen LPS-Flex/ LPS-Mobile Bearing Knee
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S079
Product code: NJL
Decision date: 2022-05-20
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Change in the gamma sterilization process monitoring, including a substantiation dose change, new master products, and bioburden alert limits.

Current openFDA PMA Record#

Device: NexGen LPS-Flex/ LPS-Mobile Bearing Knee
Applicant: Zimmer, Inc.
PMA number: P060037
Supplement: S079
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-05-20
Decision code: OK30
Date received: 2022-05-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the gamma sterilization process monitoring, including a substantiation dose change, new master products, and bioburden alert limits.