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

    ASCENSION PYROSPHERE (PCS)

    K Number: K042690 · Decision Nov 13, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    25
    Applicant Total
    22
    Review Days
    45

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    Basic Information

    Device Name
    ASCENSION PYROSPHERE (PCS)
    K Number
    K042690
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3770
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedics, Inc.
    Date Received
    September 29, 2004
    Decision Date
    November 13, 2004
    Product Code
    KYI
    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
    KYI Prosthesis, Wrist, Carpal Trapezium

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    Other Clearances by Ascension Orthopedics, Inc.

    K Number Device Name
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    K100448 ASCENSION MODULAR TOTAL SHOULDER SYSTEM
    K100502 ASCENSION TOTAL PLATE SYSTEM
    K100925 ASCENSION ANKLE FUSION NAIL SYSTEM
    K100176 ASCENSION ANKLE FUSION PLATE SYSTEM
    K092047 ASCENSION METAL GREAT TOE SYSTEM
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