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 | S318 |
Date Received | 12/18/2023 |
Decision Date | 01/12/2024 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement an equipment change from the current Neodymium Yttrium Aluminum Garnet (YAG) laser equipment to Ultraviolet (UV) laser equipment for direct marking of UHMWPE components of the LCS Total Knee System at an approved supplier Orchid Orthopedic Solutions |
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