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

    ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

    K Number: K260549 · Decision Apr 24, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    5
    Review Days
    65

    Basic Information

    Device Name
    ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
    K Number
    K260549
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zsfab, Inc.
    Date Received
    February 18, 2026
    Decision Date
    April 24, 2026
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

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    Other Clearances by Zsfab, Inc.

    K Number Device Name
    K252610 ZSFab Lumbar Interbody System
    K232150 ZSFab Cervical Interbody System
    K221858 ZSFab Lumbar Interbody System
    K202488 ZSFab Cervical Interbody System