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510(k) Data Aggregation

    K Number
    K232150
    Device Name
    ZSFab Cervical Interbody System
    Manufacturer
    ZSFab Inc.
    Date Cleared
    2023-08-18

    (30 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZSFab Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine. Implants having a lordotic angulation >10° are required to be used with an anterior cervical plate as the form of supplemental fixation.
    Device Description
    The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 500-920μm and maior axis length of 810-1390μm. Each interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.
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    K Number
    K202488
    Device Name
    ZSFab Cervical Interbody System
    Manufacturer
    ZSFab Inc.
    Date Cleared
    2021-01-07

    (129 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZSFab Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.
    Device Description
    The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 720-760μm and major axis length of 1030-1060μm. Each interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.
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