PMA P250042S001

Device: BAGUERA®C Cervical Disc Prosthesis
Applicant: Spineart USA, Inc.
PMA number: P250042
Supplement: S001
Product code: MJO
Decision date: 2026-08-27
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: addition of a new raw material supplier, Industriekeramik Hochrhein (IKH), for titanium powder used in the plasma spray coating of BAGUERA® C inferior and superior endplates

Current openFDA PMA Record#

Device: BAGUERA®C Cervical Disc Prosthesis
Applicant: Spineart USA, Inc.
PMA number: P250042
Supplement: S001
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2026-08-27
Decision code: OK30
Date received: 2026-08-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a new raw material supplier, Industriekeramik Hochrhein (IKH), for titanium powder used in the plasma spray coating of BAGUERA® C inferior and superior endplates