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

    enHAnce PEEK Bunion System

    K Number: K253718 · Decision Apr 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    24
    Review Days
    128

    Basic Information

    Device Name
    enHAnce PEEK Bunion System
    K Number
    K253718
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nvision Biomedical Technologies, Inc.
    Date Received
    November 24, 2025
    Decision Date
    April 1, 2026
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Nvision Biomedical Technologies, Inc.

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