PMA P060037S037

Device
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S037
Product code
NJL
Decision date
2015-07-23
Classification
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
INTRODUCTION OF AN ADDITIONAL UPGRADE LINE, WATER GENERATION SYSTEM, AND CLEANROOM.

Current openFDA PMA Record#

Device
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S037
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2015-07-23
Decision code
OK30
Date received
2015-06-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
INTRODUCTION OF AN ADDITIONAL UPGRADE LINE, WATER GENERATION SYSTEM, AND CLEANROOM.