Cleared Traditional

Phantom Fibula Nail System

K234128 · Paragon 28, Inc. · Orthopedic
Aug 2024
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K234128 is an FDA 510(k) clearance for the Phantom Fibula Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on August 22, 2024, 238 days after receiving the submission on December 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K234128 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2023
Decision Date August 22, 2024
Days to Decision 238 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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