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

    THE NAUTILUS NASAL IMPLANT

    K Number: K902283 · Decision Aug 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    41
    Applicant Total
    7
    Review Days
    84

    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
    THE NAUTILUS NASAL IMPLANT
    K Number
    K902283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Applied Biomaterial Technologies
    Date Received
    May 22, 1990
    Decision Date
    August 14, 1990
    Product Code
    FZE
    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
    FZE Prosthesis, Nose, Internal

    Similar 510(k) Clearances

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

    Medicon Epiplating System

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

    Osseointegrated Fixtures

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

    HANSON MEDICAL FACIAL IMPLANTS

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

    NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)

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

    MONARCH NASAL IMPLANT

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

    MONARCH NASAL IMPLANT

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

    Other Clearances by Applied Biomaterial Technologies

    K Number Device Name
    K945552 DURALASTIC SHEETING
    K935571 DURALASTIC SHEETING
    K931500 THE PERMARIDGE MATRIX CHIN
    K913768 PEC IMPLANT
    K902285 THE MAGNUM CHIN IMPLANT
    K902284 ZYMALAR IMPLANT