BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    OTIS-C PLUS

    K Number: K120818 · Decision Apr 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    6
    Review Days
    31

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    Basic Information

    Device Name
    OTIS-C PLUS
    K Number
    K120818
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Science For Biomaterials
    Date Received
    March 19, 2012
    Decision Date
    April 19, 2012
    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 Science For Biomaterials

    K Number Device Name
    K140226 OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
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    K071155 MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
    K070507 MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
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