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

    COMPREHENSIVE HUMERAL FRACTURE SYSTEM

    K Number: K023063 · Decision Dec 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    70
    Applicant Total
    34
    Review Days
    88

    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
    COMPREHENSIVE HUMERAL FRACTURE SYSTEM
    K Number
    K023063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3650
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Orthopedics, Inc.
    Date Received
    September 16, 2002
    Decision Date
    December 13, 2002
    Product Code
    KWT
    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
    KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

    Similar 510(k) Clearances

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

    Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tornier Humeral Reconstruction System Max (Tornier HRS Max)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGILON® XO Shoulder Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InSet Total Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AGILON® XO Shoulder Replacement System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Comprehensive Segmental Revision System(SRS)

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

    Other Clearances by Biomet Orthopedics, Inc.

    K Number Device Name
    K080528 E-POLY TIBIAL BEARINGS
    K072879 INNERVUE DIAGNOSTIC SCOPE SYSTEM
    K070955 ACID ETCHED LAG SCREWS
    K033355 LACTOSCREW SCREW ANCHOR
    K032286 CALCIGEN PSI BONE GRAFT SUBSTITUTE
    K030048 HA PMI FEMORAL HIP STEM
    K024086 PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
    K023188 PRESS-FIT HEAD RESURFACING DEVICE
    K023357 ARCPM 1050 RESIN-HIPS
    K021661 RINGLOC CONSTRAINED LINERS
    Search all 34 clearances from Biomet Orthopedics, Inc. →