BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENHATCH, INC

    Reg #: 3030409224 · FEI: 3030409224 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

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    Registration Details

    Registration Name
    ENHATCH, INC
    Registration Number
    3030409224
    FEI Number
    3030409224
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    411 State Rt 17 Ste 500
    City
    Hasbrouck Heights
    State
    NJ
    ZIP
    07604
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230850

    Owner / Operator

    Firm Name
    Enhatch, Inc
    Operator Number
    10089831
    Address
    411 State Route 117, Suite 500
    City
    Hasbrouck Heights
    State
    NJ
    Postal Code
    07604
    Country
    US
    Correspondent
    Monica Williams

    Products

    Device Name Product Code
    Knee Arthroplasty Implantation System OOG
    Orthopaedic Surgical Planning And Instrument Guides PBF
    System, Image Processing, Radiological LLZ

    Proprietary Names

    United Orthopedic Knee Patient Specific Instrumentation Intelligent Surgery Knee

    Establishment Types

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