BEUDAMED
    FDA Registration Active 🇺🇸 United States

    E. BAC SI IMPORTS LLC

    Reg #: 3006085220 · FEI: 3006085220 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    16

    Registration Details

    Registration Name
    E. BAC SI IMPORTS LLC
    Registration Number
    3006085220
    FEI Number
    3006085220
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    631 Canyon Rivers Edge Road
    City
    Ellensburg
    State
    WA
    ZIP
    98926
    Country
    US

    Regulatory Submissions

    510(k) Number
    K992394

    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, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Orthosis, Cervical IQK
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Joint, Knee, External Brace ITQ
    Sling, Arm ILI
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Orthosis, Limb Brace IQI
    Orthosis, Truncal/Orthosis, Limb MRI
    Exerciser, Powered BXB
    Splint, Hand, And Components ILH
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Components, Exercise IOD
    Prosthesis, Hip, Femoral, Resurfacing KXA

    Proprietary Names

    Buechel-Pappas Humeral Head Resurfacing Component Cervical Collar Brace Shoulder Immobilizer Buechel-Pappas Hemispherical Acetabular Component New Jersey Acetabular Component and New Jersey Cancellous Bone Screws Femoral Heads/Modular Fixed with Titanium Nitride Ankle Brace With Stays; Knee Immobilizer Arm Sling Preserve Acetabular Cup Modified O.E.C Universal Self-Aligning Acetabular Component Buechel-Pappas Polyethylene Glenoid Component Buechel-Pappas Extended Collar Femoral Stem Prosthesis Wrist Brace, Tennis Elbow Strap Rib Belt CPM Pad Thumb Spica Splint Buechel-Pappas Humeral Stem Component CPM Pad Kit Tronzo Acetabular Fixation Component Preserve System Preserve femoral resurfacing

    Establishment Types

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