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

    SHORTENING OSTEOTOMY GUIDE

    K Number: K861576 · Decision May 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    14

    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
    SHORTENING OSTEOTOMY GUIDE
    K Number
    K861576
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4600
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Osteotomy Guide Co.
    Date Received
    April 28, 1986
    Decision Date
    May 12, 1986
    Product Code
    HTH
    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
    HTH Protractor

    Similar 510(k) Clearances

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

    REESE OSTEOTOMY GUIDE SYS

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ORTHO-LEVEL

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

    Other Clearances by Osteotomy Guide Co.

    K Number Device Name
    K860323 REESE ARTHRODESIS SCREW
    K841470 REESE OSTEOTOMY GUIDE SYS