Cleared Traditional

Grappler Suture Anchor System

K231867 · Paragon 28, Inc. · Orthopedic
Aug 2023
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K231867 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 August 21, 2023, 56 days after receiving the submission on June 26, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231867 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2023
Decision Date August 21, 2023
Days to Decision 56 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