PMA P830055S238

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S238
Product code
NJL
Decision date
2019-12-03
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Approval order statement
Approval for an increase in the inspection frequency to 100% of the box width for every batch at the polish step when manufacturing the Attune Cementless PS Femoral Product Family

Current openFDA PMA Record#

Device
LCS Total Knee System
Applicant
Depuy, Inc.
PMA number
P830055
Supplement
S238
Product code
NJL
Generic name
Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
Decision date
2019-12-03
Decision code
APPR
Date received
2019-11-05
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for an increase in the inspection frequency to 100% of the box width for every batch at the polish step when manufacturing the Attune Cementless PS Femoral Product Family