BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ORTHOGRID SYSTEMS, INC

    Reg #: 3010342382 · FEI: 3010342382 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    ORTHOGRID SYSTEMS, INC
    Registration Number
    3010342382
    FEI Number
    3010342382
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7026 S Commerce Park Dr
    City
    Midvale
    State
    UT
    ZIP
    84047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192279

    Owner / Operator

    Firm Name
    OrthoGrid Systems, Inc.
    Operator Number
    10044516
    Address
    7026 S Commerce Park Dr
    City
    Midvale
    State
    UT
    Postal Code
    84047
    Country
    US
    Correspondent
    Justin M Turner

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Medical Device Data System OUG
    Automated Radiological Image Processing Software QIH
    Template HWT
    Instrument, Quality-Assurance, Radiologic LHO

    Proprietary Names

    OrthoGrid Trauma PhantomMSK Hip, OrthoGrid Hip, PhantomMSK Hip Preservation, OrthoGrid Hip Preservation PhantomMSK Hip PhantomMSK Hip Preservation OrthoGrid Hip AI 4 HipGrid NINE D197649 PhantomMSK OrthoGrid 12-inch Calibration Array OrthoGrid 9-inch Calibration Array

    Establishment Types

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