FDA.reportPublic FDA data

PMA P060037S065

Device
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S065
Product code
NJL
Decision date
2020-07-13
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Change in the gamma sterilization process monitoring for conventional ultra-high weight polyethylene (UHMWPE) articular surface components in NexGen LPS-Flex/LPS Mobile Bearing Knee System.

Current openFDA PMA Record#

Device
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S065
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-07-13
Decision code
OK30
Date received
2020-06-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the gamma sterilization process monitoring for conventional ultra-high weight polyethylene (UHMWPE) articular surface components in NexGen LPS-Flex/LPS Mobile Bearing Knee System.