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

    Responsive Arthroscopy Interference Screw System

    K Number: K202569 · Decision Sep 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    11
    Review Days
    19

    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
    Responsive Arthroscopy Interference Screw System
    K Number
    K202569
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Responsive Arthroscopy, LLC
    Date Received
    September 4, 2020
    Decision Date
    September 23, 2020
    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 Responsive Arthroscopy, LLC

    K Number Device Name
    K253010 Mini Superhawk Suture Anchor System
    K233258 Shadow Knotless All-Suture Anchors
    K230094 Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
    K222763 Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
    K203121 Responsive Arthroscopy Thunderbolt System
    K202153 Responsive Arthroscopy Suture Anchor System
    K190446 Responsive Arthroscopy Wedge Push-In Suture Anchors
    K181076 Responsive Arthroscopy Wedge Push-In Suture Anchors
    K180951 Responsive Arthroscopy Suture Anchor System
    K180573 Responsive Arthroscopy Interference Screw System
    Search all 11 clearances from Responsive Arthroscopy, LLC →