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

    Converge

    K Number: K153573 · Decision Aug 11, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    10
    Review Days
    240

    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
    Converge
    K Number
    K153573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomedical Enterprises, Inc.
    Date Received
    December 15, 2015
    Decision Date
    August 11, 2016
    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 Biomedical Enterprises, Inc.

    K Number Device Name
    K150125 Elite Nitinol Fixation System
    K143023 Nitinol Compression Plating System
    K142292 Speed, Speed Shift, Speed Titan, Speed Arc
    K133270 SPEED ARC
    K133520 HAMMERLOCK 2
    K124022 SPEED SHIFT
    K061385 OSSTAPLE, OSSPLATE, OSSFORCE
    K023486 OSSTAPLE, MAXILLOFACIAL
    K023488 OSSTAPLE, CRANIOFACIAL