BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    OSTEOTEC SILICONE FINGER IMPLANT

    K Number: K140453 · Decision Apr 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    417

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    Basic Information

    Device Name
    OSTEOTEC SILICONE FINGER IMPLANT
    K Number
    K140453
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3230
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteotec, Ltd.
    Date Received
    February 24, 2014
    Decision Date
    April 17, 2015
    Product Code
    KYJ
    Advisory Committee
    Orthopedic
    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
    KYJ Prosthesis, Finger, Constrained, Polymer

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