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

    COLORADO II SPINAL SYSTEM

    K Number: K991031 · Decision May 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    41
    Review Days
    408

    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
    COLORADO II SPINAL SYSTEM
    K Number
    K991031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sofamor Danek USA,Inc.
    Date Received
    March 29, 1999
    Decision Date
    May 10, 2000
    Product Code
    MNH
    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
    MNH Orthosis, Spondylolisthesis Spinal Fixation

    Similar 510(k) Clearances

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

    Reliance Spinal Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CastleLoc Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FixxSure® X-Link

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spinal fixation system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANAX™ 5.5 Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HC Spinal System

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

    Other Clearances by Sofamor Danek USA,Inc.

    K Number Device Name
    K984360 COLORADO II SPINAL SYSTEM
    K992928 CD HORIZON SPINAL SYSTEM
    K991036 DANEK PLATE AND SCREW SYSTEM
    K991198 DYNA-LOK PLUS SPINAL SYSTEM
    K991364 MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
    K981676 CD HORIZON SPINAL SYSTEM
    K980184 CD SPINAL SYSTEM
    K983672 DYNA-LOK SPINAL SYSTEM
    K983706 MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
    K982990 TSRH SPINAL SYSTEM
    Search all 41 clearances from Sofamor Danek USA,Inc. →