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

    THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY

    K Number: K102549 · Decision Dec 21, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    10
    Applicant Total
    22
    Review Days
    105

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    Basic Information

    Device Name
    THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
    K Number
    K102549
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedics, Inc.
    Date Received
    September 7, 2010
    Decision Date
    December 21, 2010
    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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    K100925 ASCENSION ANKLE FUSION NAIL SYSTEM
    K100176 ASCENSION ANKLE FUSION PLATE SYSTEM
    K092047 ASCENSION METAL GREAT TOE SYSTEM
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