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

    CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)

    K Number: K233951 · Decision Mar 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    413
    Registration Numbers
    413
    Same Product Code
    873
    Applicant Total
    34
    Review Days
    103

    Basic Information

    Device Name
    CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
    K Number
    K233951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek USA, Inc.
    Date Received
    December 15, 2023
    Decision Date
    March 27, 2024
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

    Similar 510(k) Clearances

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

    KHEIRON® Spinal Fixation System, including patient specific K-ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Momentum® Posterior Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Virata Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Annex® 2 Adjacent Level System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLONNADE Posterior Screw Fixation System

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

    Other Clearances by Medtronic Sofamor Danek USA, Inc.

    K Number Device Name
    K251395 The Rialto™ SI Fusion System
    K241992 Catalyft™ LS Expandable Interbody System
    K243007 CD Horizon™ Spinal System
    K232141 CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
    K231090 Zevo Anterior Cervical Plate System
    K223764 INFINITY OCT System
    K223153 Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
    K221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM
    K212653 Catalyft LS Expandable Interbody System
    K211958 CD Horizon Spinal System
    Search all 34 clearances from Medtronic Sofamor Danek USA, Inc. →