PMA P060037S028

Device
NEXGEN LPS-FLEX MOBILE AND LPS BEARING KNEES
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S028
Product code
NJL
Decision date
2014-05-22
Classification
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
APPROVAL FOR ADDITION OF A NEW MANUFACTURING AREA WITH NEW EQUIPMENT.

Current openFDA PMA Record#

Device
NEXGEN LPS-FLEX MOBILE AND LPS BEARING KNEES
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S028
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2014-05-22
Decision code
APPR
Date received
2013-09-30
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR ADDITION OF A NEW MANUFACTURING AREA WITH NEW EQUIPMENT.