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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K261049
Device Name SCALA® TL
Applicant
Spineart SA
Chemin Du Pré-Fleuri 3
Plan-Les-Ouates,  CH 1228
Applicant Contact Estelle Godeau
Correspondent
Spineart SA
Chemin Du Pré-Fleuri 3
Plan-Les-Ouates,  CH 1228
Correspondent Contact Estelle Godeau
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/31/2026
Decision Date 08/20/2026
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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