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

    Mini Cannulated Headed and Headless Screw Set

    K Number: K183104 · Decision Jun 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    54
    Review Days
    214

    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
    Mini Cannulated Headed and Headless Screw Set
    K Number
    K183104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker GmbH
    Date Received
    November 8, 2018
    Decision Date
    June 10, 2019
    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 GmbH

    K Number Device Name
    K253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
    K253202 Hoffmann LRF System
    K251400 T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
    K250163 T2 Alpha Femur Retrograde Nailing System
    K242445 Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
    K233919 VariAx 2 Distal Radius System
    K233741 Hoffmann LRF System
    K231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
    K231257 Pangea Utility Plating System, Pangea Platform
    K230512 Gamma4 System
    Search all 54 clearances from Stryker GmbH →