BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SimpliFix Hip System

    Reg #: 3014104093 · FEI: 3014104093 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STABILIZ ORTHOPAEDICS
    Registration Number
    3014104093
    FEI Number
    3014104093
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Eagleview Blvd Ste 300
    City
    Exton
    State
    PA
    ZIP
    19341
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230053

    Owner / Operator

    Firm Name
    Stabiliz Orthopaedics, Inc.
    Operator Number
    10056194
    Address
    600 Eagleview Blvd, Suite 300
    City
    Exton
    State
    PA
    Postal Code
    19341
    Country
    US
    Correspondent
    Doug Cerynik

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC

    Proprietary Names

    SimpliFix Hip System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198