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Spinal Frontiers · Regulatory Watch · FDA decision

FDA approves Spineart's BAGUERA C cervical disc for one or two levels

FDA decision · Spineart

10 August 2026

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

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