BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Affirm 800

    Reg #: 3015180671 · FEI: 3015180671 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DIGITAL SURGERY SYSTEMS, INC
    Registration Number
    3015180671
    FEI Number
    3015180671
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    125 Cremona Drive, Suite 110
    City
    Goleta
    State
    CA
    ZIP
    93117
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243077

    Owner / Operator

    Firm Name
    Digital Surgery Systems
    Operator Number
    10059141
    Address
    125 Cremona Drive, Suite 110
    City
    Goleta
    State
    CA
    Postal Code
    93117
    Country
    US
    Correspondent
    Lu Ju

    Products

    Device Name Product Code
    System, X-Ray, Angiographic IZI

    Proprietary Names

    Affirm 800

    Establishment Types

    Manufacture Medical Device