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

    LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW

    K Number: K013557 · Decision Nov 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    56
    Review Days
    23

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    Basic Information

    Device Name
    LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
    K Number
    K013557
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Walter Lorenz Surgical, Inc.
    Date Received
    October 24, 2001
    Decision Date
    November 16, 2001
    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 Walter Lorenz Surgical, Inc.

    K Number Device Name
    K063386 LORENZ ORTHODONTIC ANCHORAGE SYSTEM
    K063052 LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
    K063506 LORENZ STERNAL CLOSURE SYSTEM
    K062842 TWIST DRILL
    K061384 LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM
    K042516 OTOMIMIX
    K030425 LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
    K040990 MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
    K040983 LORENZ SELF-DRILLING IMF SCREW
    K033740 LORENZ STERNAL CLOSURE SYSTEM
    Search all 56 clearances from Walter Lorenz Surgical, Inc. →