PMA P830055S240

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S240
Product code
NJL
Decision date
2019-12-04
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Addition of an additional CNC machine for manufacture of the Attune Rotating Platform Tray components.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S240
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2019-12-04
Decision code
OK30
Date received
2019-11-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an additional CNC machine for manufacture of the Attune Rotating Platform Tray components.