BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OsteoFab Patient Specific Facial Device

    Reg #: 3009582362 · FEI: 3009582362 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    OXFORD PERFORMANCE MATERIALS, INC.
    Registration Number
    3009582362
    FEI Number
    3009582362
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30 South Satellite Road
    City
    South Windsor
    State
    CT
    ZIP
    06074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133809

    Owner / Operator

    Firm Name
    Oxford Performance Materials, Inc.
    Operator Number
    10043473
    Address
    30 South Satellite Road
    City
    South Windsor
    State
    CT
    Postal Code
    06074
    Country
    US
    Correspondent
    James Porteus

    Products

    Device Name Product Code
    Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction KKY

    Proprietary Names

    OsteoFab Patient Specific Facial Device HTR-PEKK

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device