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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K243190
Device Name USTOMED Bone Fixation/Bone Augmentation Systems - PIN
Applicant
Ustomed Instrumente Ulrich Storz GmbH & Co. KG
Bischof Sproll St. 2
Tuttlingen,  DE 78532
Applicant Contact Alexander Schwoy
Correspondent
Business Support International
Aalsmeerweg 123-3
Amsterdam,  NL 1059AH
Correspondent Contact Angelika Scherp
Regulation Number872.4880
Classification Product Code
DZL  
Date Received09/30/2024
Decision Date 06/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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