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

    NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM

    K Number: K022231 · Decision Sep 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    9
    Review Days
    65

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    Basic Information

    Device Name
    NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
    K Number
    K022231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteomedics, Inc.
    Date Received
    July 10, 2002
    Decision Date
    September 13, 2002
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Osteomedics, Inc.

    K Number Device Name
    K022035 OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
    K022324 NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
    K022230 NORMED MINI EXTERNAL FIXATOR SYSTEM
    K022323 NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
    K022325 NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
    K021341 NORMED BONE TRANSPORT DISTRACTION DEVICE
    K021342 NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
    K010118 NORMED MANDIBULAR FIXATION SYSTEM