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

    ZESPIN SI Joint Fusion System

    K Number: K223521 · Decision Jan 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    130
    Applicant Total
    5
    Review Days
    58

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    Basic Information

    Device Name
    ZESPIN SI Joint Fusion System
    K Number
    K223521
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aegis Spine, Inc.
    Date Received
    November 23, 2022
    Decision Date
    January 20, 2023
    Product Code
    OUR
    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
    OUR Sacroiliac Joint Fixation

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    Other Clearances by Aegis Spine, Inc.

    K Number Device Name
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    K221719 ABTross ALIF Expandable Cage System
    K221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
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