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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Instruments Designed For Use With Total Disc Replacement Devices
510(k) Number K262639
Device Name BAGUERA® C Cervical Disc Surgical Instruments
Applicant
Spineart SA
Chemin Du Pre-Fleuri 3
Plan-Les-Ouates,  CH 1228
Applicant Contact Estelle Godeau
Correspondent
Spineart SA
Chemin Du Pre-Fleuri 3
Plan-Les-Ouates,  CH 1228
Correspondent Contact Estelle Godeau
Classification Product Code
QLQ  
Date Received07/29/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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