BEUDAMED
    FDA Registration Active 🇺🇸 United States

    4CIS® Dunes PEEK DLIF Cage

    Reg #: 3010509633 · FEI: 3010509633 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    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
    K190563

    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
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    4CIS® Dunes PEEK DLIF Cage 4CIS® Augusta PEEK ALIF Cage 4CIS® Pebble Beach PEEK PLIF Cage 4CIS® Torrey Pines PEEK TLIF Cage 4CIS® PEEK PLIF Cage

    Establishment Types

    Repack or Relabel Medical Device