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

    Endoskeleton™ Interbody Systems

    K Number: K251444 · Decision Sep 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    171
    Review Days
    118

    Basic Information

    Device Name
    Endoskeleton™ Interbody Systems
    K Number
    K251444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek USA, Inc.
    Date Received
    May 9, 2025
    Decision Date
    September 4, 2025
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    Similar 510(k) Clearances

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

    Fule Interbody Fusion Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Exceed® Biplanar Expandable Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BMD Titanium Spinal Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ventana® P/T Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VersaLift Expandable System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system

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

    Other Clearances by Medtronic Sofamor Danek USA, Inc.

    K Number Device Name
    K253656 OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
    K260216 CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System
    K254165 Infinity™ OCT System
    K253941 CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
    K253335 CD Horizon™ Spinal System
    K253129 Infinity™ OCT System
    K251395 The Rialto™ SI Fusion System
    K250669 Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
    K241992 Catalyft™ LS Expandable Interbody System
    K243007 CD Horizon™ Spinal System
    Search all 171 clearances from Medtronic Sofamor Danek USA, Inc. →