Cleared Special

Grappler Interference Screw System

K241864 · Paragon 28, Inc. · Orthopedic
Jul 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K241864 is an FDA 510(k) clearance for the Grappler Interference Screw 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 July 25, 2024, 28 days after receiving the submission on June 27, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K241864 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2024
Decision Date July 25, 2024
Days to Decision 28 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