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

    RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL

    K Number: K140324 · Decision Jul 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    2
    Review Days
    147

    Basic Information

    Device Name
    RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
    K Number
    K140324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY
    Date Received
    February 10, 2014
    Decision Date
    July 7, 2014
    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 DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY

    K Number Device Name
    K140643 GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY