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

    Grappler Suture Anchor System

    K Number: K231867 · Decision Aug 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    34
    Review Days
    56

    Basic Information

    Device Name
    Grappler Suture Anchor System
    K Number
    K231867
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paragon 28, Inc.
    Date Received
    June 26, 2023
    Decision Date
    August 21, 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.

    Arthrex PushLock Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SnugFit ASA Extension

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONMED Argo Knotless® Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Shoulder Soft Tissue Anchors

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

    Other Clearances by Paragon 28, Inc.

    K Number Device Name
    K250641 APEX 3D Total Ankle Replacement System
    K242452 Monkey Bars Pin to Bar External Fixation System
    K234128 Phantom Fibula Nail System
    K241864 Grappler Interference Screw System
    K240259 APEX 3D Total Ankle Replacement System
    K241262 Baby Gorilla/Gorilla Plating System; Monster Screw System
    K240594 Grappler Suture Anchor R3FLEX IOL System
    K232838 Monkey RingsTM External Fixation System
    K223589 Grappler Suture Anchor R3FLEX IOL System
    K223056 JAWS Nitinol Staple System
    Search all 34 clearances from Paragon 28, Inc. →