BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Super Upper Limbs Versalock Plating System

    K Number: K260390 · Decision Mar 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    13
    Review Days
    39

    Basic Information

    Device Name
    Super Upper Limbs Versalock Plating System
    K Number
    K260390
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GM Dos Reis Industria e Comercio Ltda.
    Date Received
    February 6, 2026
    Decision Date
    March 17, 2026
    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 GM Dos Reis Industria e Comercio Ltda.

    K Number Device Name
    K254188 Meniscus Versaflex
    K252664 GMReis Suture Anchors
    K243905 Stitch Cerclage – Suture Tapes
    K243740 Versalock Upper Limb Plating System
    K242998 GMReis Ankle Plating System
    K242596 Versalock Mini and Micro Plating System
    K242311 EXPERT - Flexible Joint Fixation System
    K232829 Versalock Rib and Sternum Plates System
    K231684 Quick - Radius Disposable Set
    K230397 Cut Screw - Percutaneous Compression Screw
    Search all 13 clearances from GM Dos Reis Industria e Comercio Ltda. →