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

    MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA

    K Number: K922489 · Decision Sep 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    98

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA
    K Number
    K922489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Porex Technologies Corp.
    Date Received
    May 27, 1992
    Decision Date
    September 2, 1992
    Product Code
    FWP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FWP Prosthesis, Chin, Internal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FWP), ordered by most recent decision date.

    MEDPOR Customized Implant Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FITme Customized Silicone Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Customized Contour Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Customized Contour Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Stryker CMF MEDPOR Priority Customized Implant Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Stryker CMF MEDPOR Customized Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Porex Technologies Corp.

    K Number Device Name
    K971583 MEDPOR OCULAR SCREW AND ACCEOSSORIES