BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    TRIFT 3.5mm 1/3 Tubular Plate, 11 Hole (B-210011)

    Reg #: 3024890263 · FEI: 3024890263 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Zanol GmbH
    Registration Number
    3024890263
    FEI Number
    3024890263
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Langfeldweg 16
    City
    Neunkirch Schaffhausen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K203002

    Owner / Operator

    Firm Name
    Zanol GmbH
    Operator Number
    10086122
    Address
    Langfeldweg 16
    City
    Neunkirch
    State
    Schaffhausen
    Postal Code
    8213
    Country
    CH
    Correspondent
    Jens Storz

    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

    Proprietary Names

    TRIFT 3.5mm 1/3 Tubular Plate, 11 Hole (B-210011) TRIFT 3.5mm 1/3 Tubular Plate, 13 Hole (B-210013) TRIFT 3.5mm 1/3 Tubular Plate, 3 Hole (B-210003) TRIFT 3.5mm 1/3 Tubular Plate, 9 Hole (B-210009) TRIFT 3.5mm 1/3 Tubular Plate, 7 Hole (B-210007) TRIFT 3.5mm 1/3 Tubular Plate, 5 Hole (B-210005)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)