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

    Vertical Expandable Prosthetic Titanium Rib

    K Number: K142587 · Decision Nov 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    64

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    Basic Information

    Device Name
    Vertical Expandable Prosthetic Titanium Rib
    K Number
    K142587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Synthes Spine, Inc.
    Date Received
    September 15, 2014
    Decision Date
    November 18, 2014
    Product Code
    MDI
    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
    MDI Prosthesis, Rib Replacement

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