BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS

    K Number: K042517 · Decision Oct 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
    K Number
    K042517
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Linvatec Biomaterials, Ltd.
    Date Received
    September 15, 2004
    Decision Date
    October 8, 2004
    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 Linvatec Biomaterials, Ltd.

    K Number Device Name
    K042966 DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H
    K042295 SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
    K032447 CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED
    K031981 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445