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

    EPOCA CUSTOM OFFSET SHOULDER SYSTEM

    K Number: K010869 · Decision Oct 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    68
    Applicant Total
    1
    Review Days
    202

    Basic Information

    Device Name
    EPOCA CUSTOM OFFSET SHOULDER SYSTEM
    K Number
    K010869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3650
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ARGOMEDICAL AG
    Date Received
    March 23, 2001
    Decision Date
    October 11, 2001
    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.

    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

    AGILON XO Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINK Embrace Shoulder System- Anatomical Configuration

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