PMA P060037S052

Device
LPS-Flex Mobile and LPS Mobioe Bearing Knee System
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S052
Product code
NJL
Decision date
2017-10-19
Classification
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Change in manufacturing materials used during the manufacturing of the device.

Current openFDA PMA Record#

Device
LPS-Flex Mobile and LPS Mobioe Bearing Knee System
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S052
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2017-10-19
Decision code
OK30
Date received
2017-09-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in manufacturing materials used during the manufacturing of the device.