Cleared Traditional

Grappler Suture Anchor System

K222091 · Paragon 28, Inc. · Orthopedic
Sep 2022
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K222091 is an FDA 510(k) clearance for the Grappler Suture Anchor 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 September 14, 2022, 61 days after receiving the submission on July 15, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K222091 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 2022
Decision Date September 14, 2022
Days to Decision 61 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