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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 Integrated Fixation, Lumbar
510(k) Number K192993
Device Name SCARLET AL-T
Applicant
Spineart
3 Chemin Du Pré Fleuri
1228 Plan Les Ouates
Geneva,  CH
Applicant Contact Franck Pennesi
Correspondent
Spineart
3 Chemin Du Pré Fleuri
1228 Plan Les Ouates
Geneva,  CH
Correspondent Contact Franck Pennesi
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received10/25/2019
Decision Date 01/22/2020
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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