BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ensemble CMC

    Reg #: 3018282363 · FEI: 3018282363 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENSEMBLE ORTHOPEDICS, INC
    Registration Number
    3018282363
    FEI Number
    3018282363
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2621 Ridgepoint Drive, Ste 100
    City
    Austin
    State
    TX
    ZIP
    78754
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201072

    Owner / Operator

    Firm Name
    Ensemble Orthopedics, Inc
    Operator Number
    10081216
    Address
    2621 Ridgepoint Drive, Ste 100
    City
    Austin
    State
    TX
    Postal Code
    78754
    Country
    US
    Correspondent
    Sandie Roth

    Products

    Device Name Product Code
    Prosthesis, Wrist, Carpal Trapezium KYI

    Proprietary Names

    Ensemble CMC

    Establishment Types

    Manufacture Medical Device