PMA P830055S275

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S275
Product code
NJL
Decision date
2021-10-01
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
DePuy Ireland (Cork, Ireland) as an alternate casting supplier.

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S275
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2021-10-01
Decision code
OK30
Date received
2021-09-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
DePuy Ireland (Cork, Ireland) as an alternate casting supplier.