Cleared Special

BIOCHARGE

K241912 · Nanofiber Solutions, LLC · Orthopedic
Jul 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K241912 is an FDA 510(k) clearance for the BIOCHARGE, 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 29, 2024, 28 days after receiving the submission on July 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241912 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2024
Decision Date July 29, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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