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

    KINETIK GREAT TOE SYSTEM

    K Number: K924724 · Decision Jan 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    10
    Applicant Total
    19
    Review Days
    471

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    Basic Information

    Device Name
    KINETIK GREAT TOE SYSTEM
    K Number
    K924724
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kinetikos Medical, Inc.
    Date Received
    September 21, 1992
    Decision Date
    January 5, 1994
    Product Code
    LZJ
    Advisory Committee
    Unknown
    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
    LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

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    Other Clearances by Kinetikos Medical, Inc.

    K Number Device Name
    K061749 ECLIPSE TOTAL ANKLE IMPLANT
    K061465 KMI CEMENT RESTRICTOR IMPLANT
    K051611 MBARESORB IMPLANT
    K041461 KMI DISTAL VOLAR RADIUS PLATE SYSTEM
    K032806 KATALYST RADIAL HEAD IMPLANT
    K040356 KOMPRESSOR SCREW SYSTEM
    K024233 KOMPRESSOR SCREW SYSTEM
    K030037 UNIVERSAL TOTAL WRIST SYSTEM
    K023770 K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
    K020554 MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
    Search all 19 clearances from Kinetikos Medical, Inc. →