BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Expandable Titanium PLIF/TLIF System

    Reg #: 3021559833 · FEI: 3021559833 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WHEELHOUSE MEDICAL
    Registration Number
    3021559833
    FEI Number
    3021559833
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    511 Jim Parker Rd
    City
    Monroe
    State
    NC
    ZIP
    28110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201024

    Owner / Operator

    Firm Name
    WHEELHOUSE MEDICAL
    Operator Number
    10084227
    Address
    511 Jim Parker Rd
    City
    Monroe
    State
    NC
    Postal Code
    28110
    Country
    US
    Correspondent
    John Souza Souza

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX

    Proprietary Names

    Expandable Titanium PLIF/TLIF System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)