PMA P060037S011

Device
NEXGEN COMPLETE KNEE SOLUTION/LEGACY KNEE - POSTERIOR STABILIZED (LPS)/LPS-FLEX MOBILE BEARING KNEE
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S011
Product code
NJL
Decision date
2009-07-06
Classification
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
CHANGES IN THE SHELL DIPPING PROCESS FOR THE DEVICE.

Current openFDA PMA Record#

Device
NEXGEN COMPLETE KNEE SOLUTION/LEGACY KNEE - POSTERIOR STABILIZED (LPS)/LPS-FLEX MOBILE BEARING KNEE
Applicant
Zimmer, Inc.
PMA number
P060037
Supplement
S011
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2009-07-06
Decision code
OK30
Date received
2009-06-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES IN THE SHELL DIPPING PROCESS FOR THE DEVICE.