Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | LCS TOTAL KNEE SYSTEM - ADDITION OF POSTERIOR STABILIZED FEMORAL AND BEARING COMPONENTS & RPII TIBIAL TRAYS & BEARING CO |
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 | S057 |
Date Received | 03/24/1998 |
Decision Date | 05/01/1998 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of posterior stabilized femoral and tibial bearing components and rotating platform (RP II) tibial trays and bearing components to the LCS(R) Total Knee System. |
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