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

    ACUFEX ENDOBUTTON SYSTEM

    K Number: K933948 · Decision Jul 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    78
    Review Days
    343

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    Basic Information

    Device Name
    ACUFEX ENDOBUTTON SYSTEM
    K Number
    K933948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acufex Microsurgical, Inc.
    Date Received
    August 12, 1993
    Decision Date
    July 21, 1994
    Product Code
    MAI
    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
    MAI Fastener, Fixation, Biodegradable, Soft Tissue

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    Other Clearances by Acufex Microsurgical, Inc.

    K Number Device Name
    K961555 ACUFEX TAG BIOABSORBABLE ANCHORS
    K961853 PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
    K954246 ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
    K952535 ACUFEX ENDOBUTTON TAPE
    K953276 ACUFEX TAG DELIVERY SYSTEM
    K953459 ACUFEX TAG ANCHOR
    K941740 ACUFEX ROTATOR CUFF FIXATION BUTTON
    K944500 ACUFEX PATELLAR BONE BLOCK SIZER
    K951859 ACUFEX ENDOBUTTON PACK
    K946346 ACUFEX TAG(R) BIOABSORBABLE ANCHORS
    Search all 78 clearances from Acufex Microsurgical, Inc. →