BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    United Orthopedic Knee Patient Specific Instrumentation

    K Number: K230850 · Decision Dec 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    267

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    United Orthopedic Knee Patient Specific Instrumentation
    K Number
    K230850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Enhatch, Inc.
    Date Received
    March 28, 2023
    Decision Date
    December 20, 2023
    Product Code
    OOG
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OOG Knee Arthroplasty Implantation System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OOG), ordered by most recent decision date.

    Triathlon AS-1

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all