BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OrthAlign, Inc.

    Reg #: 3007521480 · FEI: 3007521480 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OrthAlign, Inc.
    Registration Number
    3007521480
    FEI Number
    3007521480
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    153 Technology
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163379

    Owner / Operator

    Firm Name
    OrthAlign, Inc
    Operator Number
    10028839
    Address
    153 Technology
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Karyl Haskell

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device