BEUDAMED
    FDA Registration Active 🇫🇷 France

    Fx Shoulder Solutions SAS

    Reg #: 3009532798 · FEI: 3009532798 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    22
    Establishment Types
    4
    Classifications
    9

    Registration Details

    Registration Name
    Fx Shoulder Solutions SAS
    Registration Number
    3009532798
    FEI Number
    3009532798
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1663 rue de Majornas
    City
    Viriat Auvergne-Rhone-Alpes
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K240278

    Owner / Operator

    Firm Name
    FX Shoulder Solutions
    Operator Number
    10039598
    Address
    1663 rue de Majornas
    City
    Viriat
    State
    FR-NOTA
    Postal Code
    01440
    Country
    FR
    Correspondent
    Brian Rogers

    Products

    Device Name Product Code
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Orthopedic Manual Surgical Instrument LXH
    Rod, Fixation, Intramedullary And Accessories HSB
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC

    Proprietary Names

    Full Wedge Lateralized and Augmented Baseplates FX SOLUTIONS TiN Coated Humeral Heads SMARTLOOP Humeris 32mm Glenosphere and Humeral Cup Humelock Cemented Shoulder Humelock II Humelock Humelock Reversed Humeris® 135 Shoulder System Flexnail Humerus Wires PRCT2 FX V135 Shoulder Prosthesis Humelock II Shoulder Humelock Shoulder FX V135 Easytech HUMELOCK Humelock II Cementless Shoulder Easytech® Anatomical Shoulder System Humelock TiN Coated Glenosphere

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device