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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 K231069
Device Name PERLA® TL Posterior Thoraco-lumbar Fixation System
Applicant
Spineart SA
3 Chemin Du Pré-Fleuri
Plan-Les-Ouates,  CH 1228
Applicant Contact Franck Pennesi
Correspondent
Spineart SA
3 Chemin Du Pré-Fleuri
Plan-Les-Ouates,  CH 1228
Correspondent Contact Franck Pennesi
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI   OSH  
Date Received04/14/2023
Decision Date 10/25/2023
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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