BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Avenger Radial Head System

    Reg #: 3009540749 · FEI: 3009540749 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    33
    Establishment Types
    5
    Classifications
    1

    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

    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

    Proprietary Names

    Avenger Radial Head System APTUS and MODUS Instruments StealthFix Intraosseous Fixation System PSN Drop Rod Adapter InCore Lapidus InCore MPJ Nextra Patella Clamp Head Nextra CH Re+Line Lapidus Cut Guide Disposable Set Stratum Ankle MSP Stratum RS InCore TMT InCore Subtalar Axi+Line PediFlex PediLoc Response Spine Cannulated Screws DFOS PNP CalcShift Instrument System Lapidus Cut Guide Stratum Arcus Lapiprep Lapidus Preparation System PediFoot PediNail PediFrag LCB BandLoc

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)