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 |
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 | S081 |
Date Received | 11/06/2001 |
Decision Date | 02/05/2002 |
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 ALLOWING THE MBT REVISION TIBIAL TRAY AND TRAY COMPONENTS, E.G., AUGMENTS, STEM EXTENSIONS, TIBIAL SLEEVES, AND WEDGES, TO BE USED WITH THE ORTHOGENESIS LPS TIBIAL HINGE BEARINGS THAT WERE CLEARED IN K011810. |
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