BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Active-X Total Knee System

    DI: 09348215010959 · Model: 10-1513-0508 · SIGNATURE ORTHOPAEDICS PTY LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Active-X Total Knee System
    Primary DI
    09348215010959
    Version / Model
    10-1513-0508
    Company Name
    SIGNATURE ORTHOPAEDICS PTY LTD
    Labeler DUNS
    751993028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-22
    Public Version
    4
    Public Version Date
    2019-12-11
    Public Version Status
    Update
    Public Device Record Key
    6917ea8d-8654-4ead-b09d-fa29bebd3610

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

    GMDN Terms

    Code Name
    32832 Uncoated knee tibia prosthesis, metallic

    Identifiers

    Type ID
    Primary 09348215010959

    Premarket Submissions

    Submission Number Supplement Number
    K160159 000