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

    TRANS-ORAL DEPTH GAUGE

    K Number: K893415 · Decision Jun 7, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    36

    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
    TRANS-ORAL DEPTH GAUGE
    K Number
    K893415
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Ruggles Corp.
    Date Received
    May 2, 1989
    Decision Date
    June 7, 1989
    Product Code
    LYQ
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYQ Accessories, Fixation, Spinal Intervertebral Body

    Similar 510(k) Clearances

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

    TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    CASF DRILL GUIDE DG 170

    FDA 510(k)
    FDA Class 1 ·Orthopedic
    View all

    Other Clearances by Ruggles Corp.

    K Number Device Name
    K903485 TITANIUM MESH
    K902818 MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT
    K902819 LAMINECTOMY ROGEUR
    K902850 ZEPPELIN INSTRUMENTS