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

    BLUE ORTHOCORD SUTURE

    K Number: K043298 · Decision Dec 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    13
    Review Days
    10

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    Basic Information

    Device Name
    BLUE ORTHOCORD SUTURE
    K Number
    K043298
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Depuy Mitek
    Date Received
    November 30, 2004
    Decision Date
    December 10, 2004
    Product Code
    NEW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Depuy Mitek

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    K240441 MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
    K143475 VAPR Tripolar Suction Electrode
    K120449 HEALIX ADVANCE PEEK ANCHOR
    K080918 DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0
    K060664 FASTIN RC ANCHOR
    K041117 PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732
    K041116 SUPER QUICKANCHOR PLUS
    K041064 BIOKNOTLESS RC ANCHOR
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