Cleared Special

Rotium Bioresorbable Wick

K201414 · Nanofiber Solutions, LLC · Orthopedic

Jun 2020

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K201414 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 (Hilliard, US). The FDA issued a Cleared decision on June 25, 2020, 27 days after receiving the submission on May 29, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K201414 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2020
Decision Date	June 25, 2020
Days to Decision	27 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF