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

    GRACE DYNAMIC TORP

    K Number: K091187 · Decision Sep 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    14
    Review Days
    144

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    Basic Information

    Device Name
    GRACE DYNAMIC TORP
    K Number
    K091187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grace Medical, Inc.
    Date Received
    April 23, 2009
    Decision Date
    September 14, 2009
    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

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    Other Clearances by Grace Medical, Inc.

    K Number Device Name
    K232059 Tympanostomy Tubes
    K161376 DragonFly Surgical Drill System
    K080070 K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
    K063374 NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
    K062672 GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
    K062385 BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
    K061853 GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
    K060518 PARTIAL OSSICULAR REPLACEMENT PROSTHESES
    K991394 STAPES PROSTHESES
    K981575 TYMPANOSTOMY TUBE
    Search all 14 clearances from Grace Medical, Inc. →