BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    PALAMED

    K Number: K030904 · Decision Sep 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    71
    Applicant Total
    1
    Review Days
    183

    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
    PALAMED
    K Number
    K030904
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heraeus Medical GmbH Technology
    Date Received
    March 24, 2003
    Decision Date
    September 23, 2003
    Product Code
    LOD
    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
    LOD Bone Cement

    Similar 510(k) Clearances

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

    Refobacin Bone Cement R (110034355)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRUM GV Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSTEOPAL® V

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRUM® GV Bone Cement

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bone Cement Genta, Bone Cement HV, Bone Cement LV

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bone Cement-Normal Viscosity

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all