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PMA P830055S258

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S258
Product code
NJL
Decision date
2020-11-10
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Addition of a supplier for the titanium alloy reinforcing pin component of the ATTUNE Revision CRS (Constrained Revision System) Rotation Platform (RP) Tibial Inserts manufactured at the DePuy Cork facility.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S258
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2020-11-10
Decision code
OK30
Date received
2020-10-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a supplier for the titanium alloy reinforcing pin component of the ATTUNE Revision CRS (Constrained Revision System) Rotation Platform (RP) Tibial Inserts manufactured at the DePuy Cork facility.