Cleared Special

Iconix? Anchor

K241577 · Riverpoint Medical · Orthopedic
Jul 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241577 is an FDA 510(k) clearance for the Iconix? Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on July 3, 2024, 30 days after receiving the submission on June 3, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K241577 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2024
Decision Date July 03, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040