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

    Asnis JFX System

    K Number: K153154 · Decision Dec 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    25
    Review Days
    56

    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
    Asnis JFX System
    K Number
    K153154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Trauma AG
    Date Received
    November 2, 2015
    Decision Date
    December 28, 2015
    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 Stryker Trauma AG

    K Number Device Name
    K172210 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    K151178 VariAx 2 Wrist Fusion System
    K143138 AxSOS 3 Ti Locking Plate System
    K140961 HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
    K141992 VARIAX 2 SYSTEM
    K141677 VARIAX ELBOW PLATING SYSTEM
    K141204 VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
    K141121 AXSOS 3 TI LOCKING PLATE SYSTEM
    K140565 VARIAX 2 COMPRESSION PLATING SYSTEM
    K140769 VARIAX 2 SYSTEM
    Search all 25 clearances from Stryker Trauma AG →