BEUDAMED
    FDA Registration Active 🇫🇷 France

    FH INDUSTRIE

    Reg #: 3003898228 · FEI: 3003898228 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    FH INDUSTRIE
    Registration Number
    3003898228
    FEI Number
    3003898228
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ZI DE KERNEVEZ-6 RUE NOBEL
    City
    QUIMPER Finistere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K112193

    Owner / Operator

    Firm Name
    FH ORTHOPEDICS INC
    Operator Number
    9025586
    Address
    ORTHO EXPRESS LLC, 7327 E. TIERRA BUENA LANE
    City
    Scottsdale
    State
    AZ
    Postal Code
    85260
    Country
    US

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240117

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Screw, Fixation, Bone HWC
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    System, Image Processing, Radiological LLZ
    Rod, Fixation, Intramedullary And Accessories HSB
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE

    Proprietary Names

    Instrument set ARROW reverse shoulder system BePOD EZ WEIL Screws ARROW Anatomical Porous Glenoid JARVIS Diaphyseal Stem Standard ARROW Short Stem Humeral System ARROW Off-Centred Humeral Insert ARROW® Reverse Shoulder long keel and short keel glenoid base JARVIS Metaphyseal Stem CoLS PEEK CoLS Fixation System BePOD Cannulated Arthrodesis screws JARVIS Glenoid Reverse Shoulder Prosthesis e-Ortho Shoulder Software v1.1 TELEGRAPH EVOLUTION Humeral Nailing System e-Ortho Shoulder Software ARROW® Reverse Porous Glenoid ARROW Humeral stems size 6 and 16 CALCANAIL Orthopedic Nail Arthrodesis BePOD Foot Screws CALCANAIL Orthopedic Nail Fracture ARROW anatomical shoulder system

    Establishment Types

    Manufacture Medical Device