BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AlignX Ankle Fusion System

    Reg #: 3007289093 · FEI: 3007289093 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    2

    Registration Details

    Registration Name
    Extremity Medical, LLC
    Registration Number
    3007289093
    FEI Number
    3007289093
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    300 Interpace Pkwy, Building A, 2nd Floor
    City
    Parsippany
    State
    NJ
    ZIP
    07054
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181067

    Owner / Operator

    Firm Name
    Extremity Medical, LLC
    Operator Number
    10027988
    Address
    300 Interpace Parkway, Building A, 2nd Floor
    City
    Parsippany
    State
    NJ
    Postal Code
    07054
    Country
    US

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS
    Screw, Fixation, Bone HWC

    Proprietary Names

    AlignX Ankle Fusion System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device