BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GSS Pedicle Screw System

    Reg #: 3008850074 · FEI: 3008850074 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GS Solutions, Inc.
    Registration Number
    3008850074
    FEI Number
    3008850074
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3210 S Susan St
    City
    Santa Ana
    State
    CA
    ZIP
    92704
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053573

    Owner / Operator

    Firm Name
    GS Solutions, Inc.
    Operator Number
    10035190
    Address
    3210 S Susan St
    City
    Santa Ana
    State
    CA
    Postal Code
    92704
    Country
    US
    Correspondent
    James (Hanjin) Shin

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH

    Proprietary Names

    GSS Pedicle Screw System

    Establishment Types

    Repack or Relabel Medical Device