Cleared Special

ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor

K240407 · Stryker Endoscopy · Orthopedic
Mar 2024
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K240407 is an FDA 510(k) clearance for the ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on March 7, 2024, 27 days after receiving the submission on February 9, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K240407 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2024
Decision Date March 07, 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