BEUDAMED
    FDA 510(k) Substantially Equivalent for Some Indications 🇺🇸 United States

    KSF SPINAL FIXATOR

    K Number: K931488 · Decision Jan 21, 1994
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    302

    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
    KSF SPINAL FIXATOR
    K Number
    K931488
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Franklin Medical USA, Inc.
    Date Received
    March 25, 1993
    Decision Date
    January 21, 1994
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Other Clearances by Franklin Medical USA, Inc.

    K Number Device Name
    K884589 FRANTZ MEDICAL SHARPS COLLECTOR
    K862478 HAYES VAGINAL SHIELD
    K852200 SIMPLASTIC SUPRA PUBIC CATHETER