PMA P830055S284

Device
LCS® Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S284
Product code
NJL
Decision date
2022-03-24
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval for including instructions on taping method for final shipper boxes and addition of inspection of the package before shipping process.

Current openFDA PMA Record#

Device
LCS® Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S284
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2022-03-24
Decision code
APPR
Date received
2022-02-22
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for including instructions on taping method for final shipper boxes and addition of inspection of the package before shipping process.