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

    X-Pac Expandable Lumbar Cage System

    K Number: K222797 · Decision Oct 14, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    X-Pac Expandable Lumbar Cage System
    K Number
    K222797
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Expanding Innovations, Inc.
    Date Received
    September 16, 2022
    Decision Date
    October 14, 2022
    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 Expanding Innovations, Inc.

    K Number Device Name
    K251003 X-PAC® LLIF Expandable Lateral Cage System
    K251617 X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System
    K250602 X-PAC® N-GAGE™ Lumbar Plate System
    K223174 X-Pac Expandable LLIF Cage System
    K220655 X-Pac Expandable Lumbar Cage System
    K203802 X-Pac Expandable Lumbar Cage System
    K201145 X-Pac Expandable Lumbar Cage System