BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHOFUNDAMENTALS, LLC

    Reg #: 3024124172 · FEI: 3024124172 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ORTHOFUNDAMENTALS, LLC
    Registration Number
    3024124172
    FEI Number
    3024124172
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    43 Broad St Ste B403
    City
    Hudson
    State
    MA
    ZIP
    01749
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212962

    Owner / Operator

    Firm Name
    OrthoFundamentals, LLC
    Operator Number
    10085945
    Address
    43 Broad Street, B403
    City
    Hudson
    State
    MA
    Postal Code
    01749
    Country
    US
    Correspondent
    Matthew Palmer

    Products

    Device Name Product Code
    Sacroiliac Joint Fixation OUR
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    OrthoFundamentals Trellis SI Joint Fusion System And Accessories AlloGr8 Posterior Allograft System

    Establishment Types

    Manufacture Medical Device