PMA P060037S058

Device
NexGen LPS-Flex/LPS Mobile Bearing Knee System
Applicant
Zimmer, Inc.
Product code
NJL
Decision date
2019-07-22
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval for packaging changes to the LPS-Mobile Articular Surface components.

Current openFDA PMA Record#

Device
NexGen LPS-Flex/LPS Mobile Bearing Knee System
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S058
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2019-07-22
Decision code
APPR
Date received
2019-04-23
Supplement type
Real-Time Process
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for packaging changes to the LPS-Mobile Articular Surface components.