PMA P060037S068

Device
NexGen LPS-Flex and LPS Mobile Bearing Knee System
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S068
Product code
NJL
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.