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

    LOW PROFILE SLEAVE NUT ASSEMBLY

    K Number: K931208 · Decision Mar 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    16
    Review Days
    383

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    Basic Information

    Device Name
    LOW PROFILE SLEAVE NUT ASSEMBLY
    K Number
    K931208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Advanced Spine Fixation Systems, Inc.
    Date Received
    March 10, 1993
    Decision Date
    March 28, 1994
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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    Other Clearances by Advanced Spine Fixation Systems, Inc.

    K Number Device Name
    K992012 WILTSE SYSTEM
    K990845 MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
    K954770 CENTRA-LINE GRAPPLE, VARIFIX SYSTEM
    K953779 SADDLE WITH ANCHOR, STAINLESS STEEL 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
    Search all 16 clearances from Advanced Spine Fixation Systems, Inc. →