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

    AUSTIN MODIFIED TOTAL OSSICULAR REPLACE

    K Number: K823912 · Decision Jun 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    80
    Review Days
    178

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
    K Number
    K823912
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Treace Medical, Inc.
    Date Received
    December 28, 1982
    Decision Date
    June 24, 1983
    Product Code
    ETA
    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
    ETA Replacement, Ossicular Prosthesis, Total

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ETA), ordered by most recent decision date.

    mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50

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

    mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

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

    GRACE DYNAMIC TORP

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

    SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2

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

    FISCH TITANIUM MIDDLE EAR PROSTHESES

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

    KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM

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

    Other Clearances by Treace Medical, Inc.

    K Number Device Name
    K883727 BUCKET PROSTHESIS PORP
    K882349 MALLET, SURGICAL
    K874779 BIPOLATOR 50
    K873154 TREACE MAGNUM OTO-TOOL SYSTEM
    K872000 EYE GARD
    K870765 CANNULATED INSTRUMENT CLEANERS
    K871706 OPTHA PREP
    K870759 CLEANING SOLUTION, CATALOG NO. 8203
    K870766 PROSTHESIS WIRE
    K870760 BUR BRUSH
    Search all 80 clearances from Treace Medical, Inc. →