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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K253966
Device Name PERLA® TL Posterior Thoraco-lumbar Fixation System
Applicant
Spineart SA
Chemin Du Pré-Fleuri 3
Plan-Les-Ouates,  CH 1228
Applicant Contact Estelle Lefeuvre
Correspondent
Spineart SA
Chemin Du Pré-Fleuri 3
Plan-Les-Ouates,  CH 1228
Correspondent Contact Estelle Lefeuvre
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   PML  
Date Received12/11/2025
Decision Date 05/01/2026
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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