BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    7D Surgical System - Drill Guide

    K Number: K210555 · Decision Mar 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    9
    Review Days
    26

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    Basic Information

    Device Name
    7D Surgical System - Drill Guide
    K Number
    K210555
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    7D Surgical, Inc.
    Date Received
    February 25, 2021
    Decision Date
    March 23, 2021
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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    Other Clearances by 7D Surgical, Inc.

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    K192945 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
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