BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Novostitch Pro

    Reg #: 3009131204 · FEI: 3009131204 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CETERIX ORTHOPAEDICS, INC
    Registration Number
    3009131204
    FEI Number
    3009131204
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6500 Kaiser Dr Ste 120
    City
    Fremont
    State
    CA
    ZIP
    94555
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180531

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

    Device Name Product Code
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT

    Proprietary Names

    Novostitch Pro

    Establishment Types

    Manufacture Medical Device