BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tronzo Acetabular Fixation Component

    Reg #: 3006085220 · FEI: 3006085220 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    E. BAC SI IMPORTS LLC
    Registration Number
    3006085220
    FEI Number
    3006085220
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    631 Canyon Rivers Edge Road
    City
    Ellensburg
    State
    WA
    ZIP
    98926
    Country
    US

    Regulatory Submissions

    510(k) Number
    K963100

    Owner / Operator

    Firm Name
    E. BAC SI IMPORTS LLC
    Operator Number
    9089402
    Address
    110 W. 6th Ave, Suite 342
    City
    Ellensburg
    State
    WA
    Postal Code
    98926
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    Tronzo Acetabular Fixation Component

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility