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

    COHORT(TM) ANTERIOR PLATE SYSTEM (APS)

    K Number: K950011 · Decision Nov 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    5
    Review Days
    307

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    Basic Information

    Device Name
    COHORT(TM) ANTERIOR PLATE SYSTEM (APS)
    K Number
    K950011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Cohort Medical Products Group, Inc.
    Date Received
    January 3, 1995
    Decision Date
    November 6, 1995
    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

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    Other Clearances by Cohort Medical Products Group, Inc.

    K Number Device Name
    K964975 COHORT DISCECTOMY SYSTEMS (CDS)
    K943804 BONE SCREW
    K943472 COHORT AVB RETRACTOR SYSTEM
    K943474 CANNULATED BONE SCREW