PMA P910016S013

Device
LCS UNICOMPARTMENTAL KNEE SYSTEM
Applicant
Depuy, Inc.
PMA number
P910016
Supplement
S013
Product code
MBD
Decision date
2003-12-17
Classification
Orthopedic
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Approval order statement
APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT DEPUY IRELAND, LTD., CORK, IRELAND.

Current openFDA PMA Record#

Device
LCS UNICOMPARTMENTAL KNEE SYSTEM
Applicant
Depuy, Inc.
PMA number
P910016
Supplement
S013
Product code
MBD
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Decision date
2003-12-17
Decision code
APPR
Date received
2002-12-19
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT DEPUY IRELAND, LTD., CORK, IRELAND.