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

    POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

    K Number: K010051 · Decision Jul 13, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    230
    Applicant Total
    2
    Review Days
    186

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    Basic Information

    Device Name
    POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
    K Number
    K010051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xiros Plc
    Date Received
    January 8, 2001
    Decision Date
    July 13, 2001
    Product Code
    JDR
    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
    JDR Staple, Fixation, Bone

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    Other Clearances by Xiros Plc

    K Number Device Name
    K002172 POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)