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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K183236
Device Name Rotium Bioresorbable Wick
Applicant
Nanofiber Solutions, LLC
4389 Weaver Ct. N.
Hilliard,  OH  43026
Applicant Contact Ronald L. Bracken
Correspondent
Nanofiber Solutions, LLC
4389 Weaver Ct. N.
Hilliard,  OH  43026
Correspondent Contact Ronald L. Bracken
Regulation Number888.3030
Classification Product Code
MAI  
Date Received11/20/2018
Decision Date 03/11/2019
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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