|
Device | LCS TOTAL KNEE SYSTEM ¿ MBT REVISION TIBIAL TRAYS |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P830055 |
Supplement Number | S103 |
Date Received | 06/13/2008 |
Decision Date | 07/16/2008 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL IN-PROCESS INSPECTION TO MEASURE THE THICKNESS OF THE MBT REVISION TIBIAL TRAYS. THESE MEASUREMENTS ARE TO ENSURE PROPER IDENTIFICATION OF THE PARTS. |