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

    CYTOPLAST PTFE SUTURE

    K Number: K072076 · Decision Oct 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    16
    Applicant Total
    8
    Review Days
    93

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    Basic Information

    Device Name
    CYTOPLAST PTFE SUTURE
    K Number
    K072076
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.5035
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Osteogenics Biomedical, Inc.
    Date Received
    July 30, 2007
    Decision Date
    October 31, 2007
    Product Code
    NBY
    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
    NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

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    Other Clearances by Osteogenics Biomedical, Inc.

    K Number Device Name
    K201187 Cytoplast Titanium-Reinforced PTFE Membranes
    K171774 RPM Reinforced PTFE Mesh
    K093719 PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
    K013764 IMMIX BONE GRAFT EXTENDER
    K003028 CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
    K993610 CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
    K984230 OSTEO-MESH TM-300