BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM

    K Number: K072251 · Decision May 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    10
    Applicant Total
    24
    Review Days
    269

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    Basic Information

    Device Name
    MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
    K Number
    K072251
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merete Medical GmbH
    Date Received
    August 13, 2007
    Decision Date
    May 8, 2008
    Product Code
    LZJ
    Advisory Committee
    Unknown
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

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