BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Statera-C Spinal System

    Reg #: 3009014637 · FEI: 3009014637 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DIO MEDICAL CORPORATION
    Registration Number
    3009014637
    FEI Number
    3009014637
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2900 Potshop Ln, Suite 200
    City
    Eagleville
    State
    PA
    ZIP
    19403
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233332

    Owner / Operator

    Firm Name
    Dio Medical Corp.
    Operator Number
    10036249
    Address
    2100 Campus Lane, Suite 100
    City
    East Norriton
    State
    PA
    Postal Code
    19403
    Country
    US
    Correspondent
    Milan George

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Posterior Cervical Screw System NKG

    Proprietary Names

    Statera-C Spinal System

    Establishment Types

    Repack or Relabel Medical Device