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

    NUGAIT(TM) SUBTALAR IMPLANT SYSTEM

    K Number: K111799 · Decision Aug 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    7
    Review Days
    53

    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
    NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
    K Number
    K111799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedic
    Date Received
    June 27, 2011
    Decision Date
    August 19, 2011
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

    Similar 510(k) Clearances

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

    VEOFIX Snap Off Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoLink® & CoLag® Non-Sterile Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TriMed Compression Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex Beaming System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSIOfiber® Threaded Trimmable Fixation Nail

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TITAN Nail; APTUS K-Wire System

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

    Other Clearances by Ascension Orthopedic

    K Number Device Name
    K140463 INTEGRA EXTERNAL FIXATION SYSTEM
    K131360 INTEGRA TITANIUM BONE WEDGE
    K130050 TITAN REVERSE SHOULDER SYSTEM
    K112438 TITAN MODULAR TOTAL SHOULDER SYSTEM
    K112481 FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT
    K112278 ASCENSION NUGRIP CMC IMPLANT