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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
510(k) Number K250021
Device Name Rotium
Applicant
Nanofiber Solutions, LLC
5164 Blazer Pkwy.
Dublin,  OH  43017
Applicant Contact Jason Chakroff
Correspondent
Nanofiber Solutions, LLC
5164 Blazer Pkwy.
Dublin,  OH  43017
Correspondent Contact Jason Chakroff
Regulation Number878.3300
Classification Product Code
OWW  
Date Received01/03/2025
Decision Date 02/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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