Cleared Traditional

Monkey Bars Pin to Bar External Fixation System

K242452 · Paragon 28, Inc. · Orthopedic

Nov 2024

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K242452 is an FDA 510(k) clearance for the Monkey Bars Pin to Bar External Fixation System, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on November 1, 2024, 74 days after receiving the submission on August 19, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K242452 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2024
Decision Date	November 01, 2024
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030