BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    GYDER® Hip System

    Reg #: 3025783933 · FEI: 3025783933 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Gyder Surgical Pty Ltd
    Registration Number
    3025783933
    FEI Number
    3025783933
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30-32 Compark Circuit
    City
    Mulgrave Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K243387

    Owner / Operator

    Firm Name
    Gyder Surgical Us Inc.
    Operator Number
    10093254
    Address
    260 Woodbridge Circle
    City
    San Mateo
    State
    CA
    Postal Code
    94403
    Country
    US
    Correspondent
    Sujit Dike

    US Agent

    Business Name
    Gyder Surgical US Inc
    Contact Name
    Sujit Dike
    Address
    260 Woodbridge Cir
    City
    San Mateo
    State
    CA
    ZIP
    94403
    Country
    US
    Email
    [email protected]
    Phone
    484 8867331

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    GYDER® Hip System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility