BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Twist-Off Screws

    Reg #: 3008951116 · FEI: 3008951116 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Ortho Solutions UK Limited
    Registration Number
    3008951116
    FEI Number
    3008951116
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    West Station Business Park, Spital Road
    City
    Maldon Essex
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K163489

    Owner / Operator

    Firm Name
    Ortho Solutions UK Ltd
    Operator Number
    10035321
    Address
    West Station Buisness Park, Spital Road
    City
    Maldon
    State
    Essex
    Postal Code
    CM96FF
    Country
    GB
    Correspondent
    Jesin Synthee

    Products

    Device Name Product Code
    Washer, Bolt Nut HTN
    Screw, Fixation, Bone HWC

    Proprietary Names

    Twist-Off Screws System 26 Washer System System 26 Headed Compression Cannulated Screws System 26 Headless Compression Cannulated Screws

    Establishment Types

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