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

    SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM

    K Number: K953779 · Decision Nov 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    16
    Review Days
    85

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    Basic Information

    Device Name
    SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM
    K Number
    K953779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Advanced Spine Fixation Systems, Inc.
    Date Received
    August 14, 1995
    Decision Date
    November 7, 1995
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

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    Other Clearances by Advanced Spine Fixation Systems, Inc.

    K Number Device Name
    K992012 WILTSE SYSTEM
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    K954770 CENTRA-LINE GRAPPLE, VARIFIX SYSTEM
    K953778 SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM
    K953369 STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW
    K951308 5.8MM DIAMETER ANCHOR SCREW
    K951172 TITANIUM LOW PROFILE CROSS BAR
    K945064 SELBY INSTRUMENTATION
    K943775 SELBY INSTRUMENTATION
    K942387 SELBY INSTRUMENTATION
    Search all 16 clearances from Advanced Spine Fixation Systems, Inc. →