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

    ACUFEX TAG ANCHOR

    K Number: K953459 · Decision Aug 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    78
    Review Days
    30

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    Basic Information

    Device Name
    ACUFEX TAG ANCHOR
    K Number
    K953459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acufex Microsurgical, Inc.
    Date Received
    July 24, 1995
    Decision Date
    August 23, 1995
    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 Acufex Microsurgical, Inc.

    K Number Device Name
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    K961853 PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
    K954246 ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
    K952535 ACUFEX ENDOBUTTON TAPE
    K953276 ACUFEX TAG DELIVERY SYSTEM
    K941740 ACUFEX ROTATOR CUFF FIXATION BUTTON
    K944500 ACUFEX PATELLAR BONE BLOCK SIZER
    K951859 ACUFEX ENDOBUTTON PACK
    K946346 ACUFEX TAG(R) BIOABSORBABLE ANCHORS
    K941709 ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
    Search all 78 clearances from Acufex Microsurgical, Inc. →