BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ensemble CMC

    Reg #: 1649833 · FEI: 3001584317 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    On-X Life Technologies Inc.
    Registration Number
    1649833
    FEI Number
    3001584317
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1300 East anderson Lane, Building B
    City
    Austin
    State
    TX
    ZIP
    78752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201072

    Owner / Operator

    Firm Name
    On-X Life Technologies, Inc
    Operator Number
    10022596
    Address
    1300 E. Anderson Lane, Bldg. B
    City
    Austin
    State
    TX
    Postal Code
    78752
    Country
    US

    Products

    Device Name Product Code
    Prosthesis, Wrist, Carpal Trapezium KYI

    Proprietary Names

    Ensemble CMC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)