BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇫🇷 France

    SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION

    K Number: K940744 · Decision Jan 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    5
    Review Days
    712

    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
    SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION
    K Number
    K940744
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Sofamor Co.
    Date Received
    February 17, 1994
    Decision Date
    January 30, 1996
    Product Code
    KWQ
    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
    KWQ Appliance, Fixation, Spinal Intervertebral Body

    Similar 510(k) Clearances

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

    ARIES Anterior Cervical Plate Systems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CastleLoc-P Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    corra™ cervical plating system

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VyPlate™ Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANTERIS Thoracolumbar Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PathLoc Lumbar Plate System

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

    Other Clearances by Sofamor Co.

    K Number Device Name
    K945022 APOFIX CERVICAL SPINE FIXATION
    K934007 SOFAMOR ORFIL SPINE FIXATION SYSTEM
    K873977 NEW C-D SYSTEM FOR SPINAL SURGERY
    K843687 ROD FOR RACHIS SURGERY