FDA.reportPublic FDA data

PMA P830055S270

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S270
Product code
NJL
Decision date
2021-08-02
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval for a manufacturing site located at Smithstown Light Engineering Ltd. Smithstown Ind Estate, Shannon, Co. Clare, Ireland V14 NW92 for manufacturing the ATTUNE Cementless RP Tibial Base component of the LCS® Total Knee System.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S270
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2021-08-02
Decision code
APPR
Date received
2021-07-07
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Smithstown Light Engineering Ltd. Smithstown Ind Estate, Shannon, Co. Clare, Ireland V14 NW92 for manufacturing the ATTUNE Cementless RP Tibial Base component of the LCS® Total Knee System.