BEUDAMED
    FDA Registration Active 🇺🇸 United States

    N/A

    Reg #: 3011765094 · FEI: 3011765094 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ARCH Medical & Aerospace - Woburn
    Registration Number
    3011765094
    FEI Number
    3011765094
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    166 NEW BOSTON ST
    City
    Woburn
    State
    MA
    ZIP
    01801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092420

    Owner / Operator

    Firm Name
    Arch Medical & Aerospace LLC dba M&K Engineering Inc.
    Operator Number
    10086988
    Address
    166 New Boston Street
    City
    Woburn
    State
    MA
    Postal Code
    01801
    Country
    US

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    N/A

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)