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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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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