BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ACE 3.5MM CORTICAL BONE SCREW

    Reg #: 3011500362 · FEI: 3011500362 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPITREX ORTHOPEDICS SWITZERLAND SA
    Registration Number
    3011500362
    FEI Number
    3011500362
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Girardet 29
    City
    Le Locle Neuchatel
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K905048

    Owner / Operator

    Firm Name
    SPITREX ORTHOPEDICS SWITZERLAND SA
    Operator Number
    10047874
    Address
    Girardet 29
    City
    Le Locle
    State
    Neuchatel
    Postal Code
    2400
    Country
    CH

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 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

    Proprietary Names

    ACE 3.5MM CORTICAL BONE SCREW

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)