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

    Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology

    K Number: K241605 · Decision Sep 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    10
    Review Days
    93

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    Basic Information

    Device Name
    Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology
    K Number
    K241605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanovis, LLC
    Date Received
    June 4, 2024
    Decision Date
    September 5, 2024
    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

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    Other Clearances by Nanovis, LLC

    K Number Device Name
    K230936 Anatomic PEEK™ Cervical Fusion System with Nanotechnology
    K203452 Nano FortiFix® System
    K191822 Nano FortiCore, FortiCore
    K171312 FortiCore®
    K161485 Nanovis Intervertebral Body Fusion System and Forticore(R)
    K160874 Nanovis Intervertebral Body Fusion System and FortiCore®
    K140280 FORTICORE
    K113173 NANOVIS SPINAL SYSTEM
    K110442 NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM