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

    Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate

    K Number: K213489 · Decision Jan 27, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    8
    Review Days
    87

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
    K Number
    K213489
    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, Inc.
    Date Received
    November 1, 2021
    Decision Date
    January 27, 2022
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.

    I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Exalta Proximal Tibia Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APTUS Clavicle System 2.8

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pectus Blu System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Xpert PFP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Avanti Distal Elbow ORIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    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
    K203467 WishBone Medical Plate and Screw System
    K193368 Smart Correction System
    K180736 WishBone Medical Plate and Screw System
    K173013 WishBone K-Wire System