PMA P830055S265

Device: LCS Total Knee System
Applicant: Depuy, Inc.
Product code: NJL
Decision date: 2021-05-10
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Approval for a manufacturing site located at Johnson & Johnson Medical (DePuy Suzhou) Ltd., No. 299, Changyang Street, Suzhou Industrial Park, Suzhou Jiangsu, China, to manufacture ATTUNE CR and ATTUNE PS Femoral Components of the LCS Total Knee System.

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S265
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2021-05-10
Decision code: APPR
Date received: 2021-04-16
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 Johnson & Johnson Medical (DePuy Suzhou) Ltd., No. 299, Changyang Street, Suzhou Industrial Park, Suzhou Jiangsu, China, to manufacture ATTUNE CR and ATTUNE PS Femoral Components of the LCS Total Knee System.