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| Device | BAGUERA®C Cervical Disc Prosthesis |
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| Generic Name | Prosthesis, intervertebral disc |
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| Applicant | Spineart USA, Inc.
23332 Mill Creek Dr.
Suite 150
Laguna Hills, CA 92653 |
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| PMA Number | P250042 |
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| Date Received | 10/31/2025 |
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| Decision Date | 08/10/2026 |
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| Product Code |
MJO |
| Advisory Committee |
Orthopedic |
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| Clinical Trials | NCT04520776
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
The BAGUERA® C Cervical Disc Prosthesis is indicated for use in skeletally mature patients for reconstruction of the disc at one or two contiguous levels from C3-C7 following single-level or two-contiguous-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level or two-contiguous-level abnormality localized to the level of the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e.g., X-rays, computed tomography (CT), magnetic resonance imaging (MRI)): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. Patients receiving the BAGUERA® C Cervical Disc Prosthesis should have failed at least six weeks of non-operative treatment or have the presence of progressive symptoms (e.g., numbness or tingling) prior to implantation. The BAGUERA® C Cervical Disc Prosthesis is implanted via an open anterior approach. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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