FDA granted premarket approval for the BAGUERA C artificial disc for reconstruction at one or two contiguous levels from C3 to C7 in patients with radiculopathy or myelopathy after failed conservative care. A post-approval study protocol was approved on 22 September.
- Type
- FDA decision
- Company
- Spineart
- Device
- BAGUERA C Cervical Disc Prosthesis
- Date
- 10 August 2026
- Jurisdiction
- US
- Classification
- PMA P250042 (original approval)
- Source
- FDA PMA database
Official source →Source checked