BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HUMEROUS FRACTURE BRACE, ULNA FRACTURE

    K Number: K801788 · Decision Aug 7, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    503
    Registration Numbers
    503
    Same Product Code
    51
    Applicant Total
    9
    Review Days
    9

    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
    HUMEROUS FRACTURE BRACE, ULNA FRACTURE
    K Number
    K801788
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Hosmer Dorrance Corp.
    Date Received
    July 29, 1980
    Decision Date
    August 7, 1980
    Product Code
    IQI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IQI Orthosis, Limb Brace

    Similar 510(k) Clearances

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

    Neurosplint

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SENSOR WALK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ACCUFLEX DYNAMIC ELBOW ORTHOSIS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MCCONNELL SHOULDER BRACE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    GAIT-AID ORTHOPEDIC INSOLE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Hosmer Dorrance Corp.

    K Number Device Name
    K822632 ELBOW PROSTHESIS
    K821704 FRACTURE BRACING
    K780891 POST-OPERATIVE HIP ORTHOSIS
    K780892 FRACTURE BRACING
    K780890 CAPP TERMINAL DEVICE
    K761312 ORTHOTIC BRACING
    K761314 FLEXION-BRAKING KNEE-SHIN ASSEMBLY
    K761313 4-BAR KNEE-SHIN SET-UP