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

    Nanova Interference Screw

    K Number: K161174 · Decision Nov 3, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    8
    Review Days
    191

    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
    Nanova Interference Screw
    K Number
    K161174
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanova Biomaterials, Inc.
    Date Received
    April 26, 2016
    Decision Date
    November 3, 2016
    Product Code
    MAI
    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
    MAI Fastener, Fixation, Biodegradable, Soft Tissue

    Similar 510(k) Clearances

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

    Arthrex Bioabsorbable PushLock Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SF Push-in Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSIOfiber® Suture Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Biosteon® Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BioBrace® Extra-Articular Ligament Augmentation Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSIOfiber® Interference Screw

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

    Other Clearances by Nanova Biomaterials, Inc.

    K Number Device Name
    K172977 Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
    K171330 Nanova Sealant
    K163672 Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
    K151943 Vas-Q-Clip
    K152004 Nanova Universal Composite
    K150623 Nanova Flowable Composite
    K140349 STARBRIGHT 5% SODIUM FLUORIDE VARNISH