Cleared Special

Iconix Anchor

K233468 · Riverpoint Medical · Orthopedic
Nov 2023
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K233468 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 November 14, 2023, 21 days after receiving the submission on October 24, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K233468 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2023
Decision Date November 14, 2023
Days to Decision 21 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