BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    KeriFlex® MCP and PIP Finger Joint Prostheses

    K Number: K211385 · Decision Jul 27, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    449

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    Basic Information

    Device Name
    KeriFlex® MCP and PIP Finger Joint Prostheses
    K Number
    K211385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3230
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Keri Medical SA
    Date Received
    May 4, 2021
    Decision Date
    July 27, 2022
    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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