BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    LORRAINE 2.5/3.5mm Distal Humerus System

    Reg #: 3021010222 · FEI: 3021010222 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    BONEBRIDGE AG
    Registration Number
    3021010222
    FEI Number
    3021010222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bahnhofstrasse 11
    City
    ZUG
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K250933

    Owner / Operator

    Firm Name
    Bonebridge AG
    Operator Number
    10083420
    Address
    Bahnhofstrasse 11
    City
    ZUG
    State
    CH-ZG
    Postal Code
    6300
    Country
    CH
    Correspondent
    Michelle Gumpelmayer M.Sc.

    US Agent

    Business Name
    confinis USA Inc.
    Contact Name
    Alfred Lerch
    Address
    600 Park Offices Drive Suite 300, Unit #50
    City
    Durham
    State
    NC
    ZIP
    27709
    Country
    US
    Email
    [email protected]
    Phone
    910 2289391

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    LORRAINE 2.5/3.5mm Distal Humerus System Bone Screw LE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility