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

    WishBone Guided Growth System

    K Number: K182704 · Decision Jun 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    271

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    Basic Information

    Device Name
    WishBone Guided Growth System
    K Number
    K182704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wishbone Medical
    Date Received
    September 27, 2018
    Decision Date
    June 25, 2019
    Product Code
    OBT
    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
    OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

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