Cleared Special

Rotium Bioresorbable Wick

K231641 · Nanofiber Solutions, LLC · Orthopedic

Jul 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K231641 is an FDA 510(k) clearance for the Rotium Bioresorbable Wick, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Nanofiber Solutions, LLC (Dublin, US). The FDA issued a Cleared decision on July 5, 2023, 30 days after receiving the submission on June 5, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K231641 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2023
Decision Date	July 05, 2023
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF