FDA.reportPublic FDA data

PMA P830055S260

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S260
Product code
NJL
Decision date
2020-12-02
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Use of new equipment, (Cellro) Laser Marking System (LMS), for application of a 2D barcode and human readable text to the PFC Sigma Posterior and Distal Femoral Augment components.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S260
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-12-02
Decision code
OK30
Date received
2020-11-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of new equipment, (Cellro) Laser Marking System (LMS), for application of a 2D barcode and human readable text to the PFC Sigma Posterior and Distal Femoral Augment components.