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

    SPINE FIXATION

    K Number: K943827 · Decision Feb 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    326
    Registration Numbers
    326
    Same Product Code
    308
    Applicant Total
    56
    Review Days
    558

    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
    SPINE FIXATION
    K Number
    K943827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Danek Medical, Inc.
    Date Received
    August 5, 1994
    Decision Date
    February 14, 1996
    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 Danek Medical, Inc.

    K Number Device Name
    K994122 BONE GRAFT WASHER, MODEL 9090114 - 9090118
    K993810 CD HORIZON SPINAL SYSTEM
    K993855 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
    K991528 MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
    K990603 MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
    K982875 MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
    K984522 MODIFICATION OF TSRH SPINAL SYSTEM
    K982154 MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
    K970599 TOWNLEY PEDICLE SCREW PLATING SYSTEM
    K943356 INCLUSIVE ENDOSCOPE
    Search all 56 clearances from Danek Medical, Inc. →