Cleared Special

Grappler Suture Anchor R3FLEX IOL System

K240594 · Paragon 28, Inc. · Orthopedic
Mar 2024
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K240594 is an FDA 510(k) clearance for the Grappler Suture Anchor R3FLEX IOL System, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on March 26, 2024, 22 days after receiving the submission on March 4, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K240594 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2024
Decision Date March 26, 2024
Days to Decision 22 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