BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Black Diamond Stereotaxic Instruments

    Reg #: 3010531060 · FEI: 3010531060 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OSSEUS FUSION SYSTEMS LLC
    Registration Number
    3010531060
    FEI Number
    3010531060
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1931 Greenville Avenue, Suite 200
    City
    Dallas
    State
    TX
    ZIP
    75206
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192495

    Owner / Operator

    Firm Name
    OSSEUS FUSION SYSTEMS LLC
    Operator Number
    10045353
    Address
    1931 Greenville Avenue, suite 200
    City
    Dallas
    State
    TX
    Postal Code
    75206
    Country
    US

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Black Diamond Stereotaxic Instruments

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility