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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 K213470
Device Name PERLA® TL Posterior Osteosynthesis System
Applicant
Spineart
3 Chemin Du Pré Fleuri
Plan Les Ouates,  CH 1228
Applicant Contact Franck Pennesi
Correspondent
Spineart
3 Chemin Du Pré Fleuri
Plan Les Ouates,  CH 1228
Correspondent Contact Franck Pennesi
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received10/28/2021
Decision Date 01/21/2022
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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