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

    BIO 1-KIT BIOSORB FILLED CARTRIDGE

    K Number: K061022 · Decision May 24, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    6
    Review Days
    41

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    Basic Information

    Device Name
    BIO 1-KIT BIOSORB FILLED CARTRIDGE
    K Number
    K061022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Science For Biomaterials
    Date Received
    April 13, 2006
    Decision Date
    May 24, 2006
    Product Code
    MQV
    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
    MQV Filler, Bone Void, Calcium Compound

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    Other Clearances by Science For Biomaterials

    K Number Device Name
    K140226 OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5
    K120818 OTIS-C PLUS
    K090994 LIGAFIX INTERFACE SCREW
    K071155 MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER
    K070507 MODIFICATION TO: LIGAFIX INTERFERENCE SCREW