PMA P250042S002

Device: BAGUERA®C Cervical Disc Prosthesis
Applicant: Spineart USA, Inc.
PMA number: P250042
Supplement: S002
Product code: MJO
Decision date: 2026-09-22
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: requested approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250042

Current openFDA PMA Record#

Device: BAGUERA®C Cervical Disc Prosthesis
Applicant: Spineart USA, Inc.
PMA number: P250042
Supplement: S002
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2026-09-22
Decision code: APPR
Date received: 2026-08-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: requested approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250042