Cleared Special

Monkey RingsTM External Fixation System

K232838 · Paragon 28, Inc. · Orthopedic

Oct 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K232838 is an FDA 510(k) clearance for the Monkey RingsTM 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 October 12, 2023, 28 days after receiving the submission on September 14, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K232838 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 14, 2023
Decision Date	October 12, 2023
Days to Decision	28 days
Submission Type	Special
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