Cleared Traditional

Grappler Suture Anchor R3FLEX IOL System

K223589 · Paragon 28, Inc. · Orthopedic
Mar 2023
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K223589 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 3, 2023, 92 days after receiving the submission on December 1, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K223589 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2022
Decision Date March 03, 2023
Days to Decision 92 days
Submission Type Traditional
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