Cleared Special

Iconix Knotless Anchor

K243323 · Riverpoint Medical · Orthopedic
Nov 2024
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K243323 is an FDA 510(k) clearance for the Iconix Knotless 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 November 19, 2024, 27 days after receiving the submission on October 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K243323 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2024
Decision Date November 19, 2024
Days to Decision 27 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