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

    BEAR (Bridge-Enhanced ACL Repair) Implant

    K Number: DEN200035 · Decision Dec 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    195

    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
    BEAR (Bridge-Enhanced ACL Repair) Implant
    K Number
    DEN200035
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    888.3044
    Medical Specialty
    Orthopedic
    Decision
    Unknown
    Applicant
    Miach Orthopaedics, Inc.
    Date Received
    June 4, 2020
    Decision Date
    December 16, 2020
    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 Restoration) 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
    K243578 BEAR® (Bridge-Enhanced ACL Restoration) Implant