BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    SnugFit All-Suture Anchor extension

    K Number: K230544 · Decision Apr 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    165
    Review Days
    48

    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
    SnugFit All-Suture Anchor extension
    K Number
    K230544
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medacta International S.A.
    Date Received
    February 28, 2023
    Decision Date
    April 17, 2023
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

    Similar 510(k) Clearances

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

    Dione PEEK Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Y-Knotless™ Flex Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anchor with Fiber Wire and Disposable Inserter

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArthroTAK Tendon Anchor Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex FiberTak Suture Anchor

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

    Other Clearances by Medacta International S.A.

    K Number Device Name
    K254202 MectaLIF 3D Metal Anterior
    K253940 M.U.S.T. Pedicle Screw System - Extension
    K253328 GMK 3D Metal Tibial Tray Extension
    K250644 MSS - Monobloc stem
    K251043 Mpact 3D Metal Implants Extension – DMLS Technology
    K252847 NextAR Hip Platform
    K242603 MyPAO SA guides
    K250338 MSS - Humeral reverse liners extension
    K250450 Coated hip implants
    K252225 PowerKnot High Strength Sutures
    Search all 165 clearances from Medacta International S.A. →