BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    VARIAX CLAVICLE - TRIAL - SUP DECREASED / 7 HOLE / LEFT

    Reg #: 3010158639 · FEI: 3010158639 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MAWATEC AG
    Registration Number
    3010158639
    FEI Number
    3010158639
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Selzacherstrasse 32
    City
    Selzach Solothurn
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K130116

    Owner / Operator

    Firm Name
    Mawatec AG
    Operator Number
    10043561
    Address
    Selzacherstrasse 32
    City
    Selzach
    State
    Solothurn
    Postal Code
    2545
    Country
    CH
    Correspondent
    Dominik Lehmann

    US Agent

    Business Name
    EMERGO GLOBAL REPRESENTATION LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Caves Rd Ste 1 Ste 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

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

    Proprietary Names

    VARIAX CLAVICLE - TRIAL - SUP DECREASED / 7 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP INCREASED / 8 HOLE / LEFT VARIAX CLAVICLE - TRIAL- ANT LATERAL / 6 HOLE VARIAX CLAVICLE - TRIAL - SUP INCREASED / 10 HOLE / RIGHT VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 7 HOLE VARIAX CLAVICLE - TRIAL- ANT LATERAL / 8 HOLE VARIAX CLAVICLE - TRIAL - SUP DECREASED / 6 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 5 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP INCREASED / 10 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP INCREASED / 8 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 4 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 10 HOLE / LEFT VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 10 HOLE VARIAX CLAVICLE - TRIAL- ANT LATERAL / 7 HOLE VARIAX CLAVICLE - TRIAL - SUP LATERAL / 7 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 3 HOLE / RIGHT VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 6 HOLE VARIAX CLAVICLE - TRIAL - SUP LATERAL / 4 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 10 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 6 HOLE / RIGHT VARIAX CLAVICLE - TRIAL- ANT MIDSHAFT / 8 HOLE VARIAX CLAVICLE - TRIAL - SUP LATERAL / 3 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 5 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 8 HOLE / LEFT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 8 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP DECREASED / 7 HOLE / RIGHT VARIAX CLAVICLE - TRIAL - SUP LATERAL / 7 HOLE / RIGHT

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)