BEUDAMED
    FDA Registration Active 🇺🇸 United States

    InCore TMT

    Reg #: 3009540749 · FEI: 3009540749 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Medartis Inc.
    Registration Number
    3009540749
    FEI Number
    3009540749
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1195 Polk Drive
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192578

    Owner / Operator

    Firm Name
    MEDARTIS AG
    Operator Number
    9033581
    Address
    HOCHBERGERSTRASSE 60E, --
    City
    BASEL
    State
    Basel-Stadt
    Postal Code
    CH-4057
    Country
    CH
    Correspondent
    Claudia De Santis

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Screw, Fixation, Bone HWC

    Proprietary Names

    InCore TMT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device