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

    ZARA CHIN IMPLANT

    K Number: K910456 · Decision Feb 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    27
    Review Days
    15

    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
    ZARA CHIN IMPLANT
    K Number
    K910456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Byron Medical
    Date Received
    February 4, 1991
    Decision Date
    February 19, 1991
    Product Code
    FWP
    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
    FWP Prosthesis, Chin, Internal

    Similar 510(k) Clearances

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

    MEDPOR Customized Implant Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FITme Customized Silicone Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Customized Contour Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Customized Contour Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Stryker CMF MEDPOR Priority Customized Implant Kit

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Stryker CMF MEDPOR Customized Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Byron Medical

    K Number Device Name
    K040149 PSI-TEC PERISTALTIC INFILTRATION PUMP
    K001803 ACCELERATOR RECIPROCATING CANNULA
    K981215 PSI-TEC LIPOSUCTION ASPIRATOR
    K981172 LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES
    K980738 PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
    K980392 PSI-TEC ASPIRATOR
    K974295 BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
    K973133 BIG BAG 3000 PRESSURE INFUSOR
    K934179 DISPOSABLE BAG DECANTER
    K934233 ZARA ZONE IV MALAR IMPLANT MODIFICATION
    Search all 27 clearances from Byron Medical →