BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SPINAL SURGERY FRAME

    K Number: K875291 · Decision Jan 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    19
    Applicant Total
    27
    Review Days
    23

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    Basic Information

    Device Name
    SPINAL SURGERY FRAME
    K Number
    K875291
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    T. Korossurgical Instruments Corp.
    Date Received
    December 30, 1987
    Decision Date
    January 22, 1988
    Product Code
    BWN
    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
    BWN Table And Attachments, Operating-Room

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    K935529 CERVICAL SELF-RETAINING RETRACTOR
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    K926583 REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR
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