BEUDAMED
    FDA Registration Active 🇺🇸 United States

    13MM WASHER

    Reg #: 3010531060 · FEI: 3010531060 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    18
    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
    K181881

    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
    Sacroiliac Joint Fixation OUR

    Proprietary Names

    13MM WASHER 13X60MM IMPLANT 11MM DRILL, CANNULATED 3.2MM STEINMANN PIN, ROUND 13X50MM IMPLANT 13X40MM IMPLANT 11MM WASHER 13X45MM IMPLANT 11X35MM IMPLANT 13X35MM IMPLANT 3.2MM STEINMANN PIN, SHARP 11X50MM IMPLANT 11X55MM IMPLANT 11X40MM IMPLANT 11X60MM IMPLANT Blue Topaz CompreSIve Sacroiliac Screw System 13X55MM IMPLANT 11X45MM IMPLANT

    Establishment Types

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