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

    TRUE/FLEX METATARSAL RODS

    K Number: K924657 · Decision Nov 24, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    37
    Applicant Total
    15
    Review Days
    70

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    Basic Information

    Device Name
    TRUE/FLEX METATARSAL RODS
    K Number
    K924657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Applied Osteo Systems, Inc.
    Date Received
    September 15, 1992
    Decision Date
    November 24, 1992
    Product Code
    KTW
    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
    KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

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    Other Clearances by Applied Osteo Systems, Inc.

    K Number Device Name
    K935383 FEMROD AND FEMROD RECON INSERT
    K933995 TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION
    K944501 TRUE/FLEX INTRAMEDULLARY ROD END-CAP
    K941048 TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
    K943160 INTERFERENCE SCREW
    K934148 TRUE/FLEX CLAVICLE RODS
    K931578 TEXAS SCOTTISH RITE EASY/LOCK FIXATOR
    K932853 PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS
    K926465 FEMORAL INTRAMEDULLARY RODS
    K924656 TRUE/ FLEX FIBULA RODS
    Search all 15 clearances from Applied Osteo Systems, Inc. →