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

    PROSTHESIS WIRE

    K Number: K870766 · Decision Apr 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    80
    Review Days
    48

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    Basic Information

    Device Name
    PROSTHESIS WIRE
    K Number
    K870766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Treace Medical, Inc.
    Date Received
    February 26, 1987
    Decision Date
    April 15, 1987
    Product Code
    ETB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETB Prosthesis, Partial Ossicular Replacement

    Similar 510(k) Clearances

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    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)

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    Other Clearances by Treace Medical, Inc.

    K Number Device Name
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    K872000 EYE GARD
    K870765 CANNULATED INSTRUMENT CLEANERS
    K871706 OPTHA PREP
    K870759 CLEANING SOLUTION, CATALOG NO. 8203
    K870760 BUR BRUSH
    K870763 SUPER SCISSORS
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