BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    360CAS

    DI: B432360CAS2100 · Model: 2.1.0 · KICO KNEE INNOVATION COMPANY PTY LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    360CAS
    Primary DI
    B432360CAS2100
    Version / Model
    2.1.0
    Company Name
    KICO KNEE INNOVATION COMPANY PTY LIMITED
    Labeler DUNS
    757918953
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-08-16
    Public Version
    2
    Public Version Date
    2023-10-20
    Public Version Status
    Update
    Public Device Record Key
    e040309d-a444-4df1-b8d2-73bea232583b

    Device Description

    360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation. The software contains two modules, 360CAS Knee and 360CAS Hip.

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OLO Orthopedic Stereotaxic Instrument

    GMDN Terms

    Code Name
    42895 Robotic surgical navigation system application software

    Identifiers

    Type ID
    Primary B432360CAS2100

    Premarket Submissions

    Submission Number Supplement Number
    K213380 000
    K223927 000