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

    OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB

    K Number: K022035 · Decision Jan 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    9
    Review Days
    210

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    Basic Information

    Device Name
    OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
    K Number
    K022035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteomedics, Inc.
    Date Received
    June 21, 2002
    Decision Date
    January 17, 2003
    Product Code
    JEY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JEY Plate, Bone

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    Other Clearances by Osteomedics, Inc.

    K Number Device Name
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    K022231 NORMED DISTAL RADIUS RECONSTRUCTION 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