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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 K231641
Device Name Rotium Bioresorbable Wick
Applicant
Nanofiber Solutions, LLC
5164 Blazer Parkway
Dublin,  OH  43017
Applicant Contact Jason Chakroff
Correspondent
Nanofiber Solutions, LLC
5164 Blazer Parkway
Dublin,  OH  43017
Correspondent Contact Jason Chakroff
Regulation Number888.3030
Classification Product Code
MAI  
Date Received06/05/2023
Decision Date 07/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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