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

    MARKER SYSTEM FOR STEREOTAXIC NAVIGATION

    K Number: K961120 · Decision May 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    246
    Registration Numbers
    246
    Same Product Code
    417
    Applicant Total
    11
    Review Days
    50

    Basic Information

    Device Name
    MARKER SYSTEM FOR STEREOTAXIC NAVIGATION
    K Number
    K961120
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HOWMEDICA LEIBINGER, INC.
    Date Received
    March 21, 1996
    Decision Date
    May 10, 1996
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

    Similar 510(k) Clearances

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

    EZ-FIDUCIALS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stereotaxic Guiding Surgical Devices, NaoTrac S

    FDA 510(k)
    FDA Class 2 ·Neurology

    Navient Image Guide Navigation System (955-NC-NC), Cranial

    FDA 510(k)
    FDA Class 2 ·Neurology

    Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT

    FDA 510(k)
    FDA Class 2 ·Neurology

    ClearPoint System (Software Version 3.0)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Geniant Cranial (Navigated Neurosurgical Positioning Robot)

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by HOWMEDICA LEIBINGER, INC.

    K Number Device Name
    K970912 LEIBINGER SELF-DRILLING SCREW
    K972154 COHEN DISTRACTOR
    K972166 GUERRERO - BELL DISTRACTOR
    K961719 EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
    K963030 LEIBINGER IMF SCREW
    K970911 LEE PLATE
    K963741 LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS
    K964649 VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE
    K963739 LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
    K963740 LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS
    Search all 11 clearances from HOWMEDICA LEIBINGER, INC. →