BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇺🇸 United States

    MITEK THREADED ANCHOR (FASTIN)

    K Number: K953560 · Decision Jan 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    31
    Review Days
    195

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    Basic Information

    Device Name
    MITEK THREADED ANCHOR (FASTIN)
    K Number
    K953560
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Mitek Surgical Products, Inc.
    Date Received
    July 20, 1995
    Decision Date
    January 31, 1996
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by Mitek Surgical Products, Inc.

    K Number Device Name
    K953877 MITEK GII ANCHOR
    K936311 MITEK MINI ANCHOR
    K941599 MITEK ABSORBABLE ANCHOR
    K944051 ABSORBALBE ANCHOR
    K950070 MITEK TOGGLE ANCHOR(TM)
    K944936 MITEK G III ANCHOR, MITEK LS ANCHOR
    K945203 MITEK THRADED ANCHOR (MTA)
    K934366 MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
    K931782 MITEK GIII ANCHOR
    K931253 QUICKANCHOR II
    Search all 31 clearances from Mitek Surgical Products, Inc. →