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

    BEAR® (Bridge-Enhanced ACL Restoration) Implant

    K Number: K243578 · Decision Mar 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    107

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    Basic Information

    Device Name
    BEAR® (Bridge-Enhanced ACL Restoration) Implant
    K Number
    K243578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3044
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miach Orthopaedics, Inc.
    Date Received
    November 19, 2024
    Decision Date
    March 6, 2025
    Product Code
    QNI
    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
    QNI Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair

    Similar 510(k) Clearances

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

    BEAR® (Bridge-Enhanced ACL Restoration) Implant

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BEAR (Bridge-Enhanced ACL Repair) Implant

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

    Other Clearances by Miach Orthopaedics, Inc.

    K Number Device Name
    K251214 BEAR® (Bridge-Enhanced ACL Restoration) Implant
    DEN200035 BEAR (Bridge-Enhanced ACL Repair) Implant