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

    WishBone Medical Plate and Screw System

    K Number: K203467 · Decision Dec 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    WishBone Medical Plate and Screw System
    K Number
    K203467
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wishbone Medical, Inc.
    Date Received
    November 25, 2020
    Decision Date
    December 23, 2020
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Wishbone Medical, Inc.

    K Number Device Name
    K231461 Smart Correction System (HA Half Pins)
    K230527 WishBone Medical Plate and Screw System
    K221366 Smart Correction System Rings and Compatible HA-Coated Half Pins
    K213489 Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
    K193368 Smart Correction System
    K180736 WishBone Medical Plate and Screw System
    K173013 WishBone K-Wire System