BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇿🇦 South Africa

    Biolign® Roto-Loc Cervical Plate System

    K Number: K200523 · Decision Apr 30, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    356
    Registration Numbers
    356
    Same Product Code
    665
    Applicant Total
    4
    Review Days
    59

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    Basic Information

    Device Name
    Biolign® Roto-Loc Cervical Plate System
    K Number
    K200523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elite Surgical Supplies (Pty), Ltd.
    Date Received
    March 2, 2020
    Decision Date
    April 30, 2020
    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 Elite Surgical Supplies (Pty), Ltd.

    K Number Device Name
    K130274 BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
    K080075 MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
    K063453 VERTEFIX PEDICLE SCREW SPINAL SYSTEM