BEUDAMED
    FDA Registration Active 🇺🇸 United States

    B-Two Vertebral access system

    Reg #: 3010509633 · FEI: 3010509633 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SOLCO BIOMEDICAL CORP.
    Registration Number
    3010509633
    FEI Number
    3010509633
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4100 Midway Rd Ste 1130
    City
    Carrollton
    State
    TX
    ZIP
    75007
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133669

    Owner / Operator

    Firm Name
    SOLCO BIOMEDICAL CORPORATION
    Operator Number
    10045137
    Address
    4100 Midway Rd. Ste 1130
    City
    Carrollton
    State
    TX
    Postal Code
    75007
    Country
    US
    Correspondent
    MIN SEOK SEO

    Products

    Device Name Product Code
    Cement, Bone, Vertebroplasty NDN
    Arthroscope HRX

    Proprietary Names

    B-Two Vertebral access system MEDINAUT Kyphoplasty System MEDINAUT-I B-Two Vertebral Balloon Expand® Kyphoplasty System B-Two Inflatable bone expander system syringe MEDINAUT-X B-Two Inflatable bone expander system balloon catheter

    Establishment Types

    Repack or Relabel Medical Device