BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mountaineer OCT Spinal System

    Reg #: 1219213 · FEI: 1219213 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Marox Corporation
    Registration Number
    1219213
    FEI Number
    1219213
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    373 WHITNEY AVE.
    City
    Holyoke
    State
    MA
    ZIP
    01040
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042508

    Owner / Operator

    Firm Name
    Paragon Medical
    Operator Number
    1219213
    Address
    8 Matchett Drive, --
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    Jim F Rogers

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP

    Proprietary Names

    Mountaineer OCT Spinal System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)