PMA P830055S292

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S292
Product code: NJL
Decision date: 2022-07-06
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement: Change to add a new laser machine for poly products and the movement of process steps from building #1 (B1) to building #2 (B2).

Current openFDA PMA Record#

Device: LCS Total Knee System
Applicant: Depuy, Inc.
PMA number: P830055
Supplement: S292
Product code: NJL
Generic name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date: 2022-07-06
Decision code: OK30
Date received: 2022-06-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to add a new laser machine for poly products and the movement of process steps from building #1 (B1) to building #2 (B2).