Cleared Traditional

Affixus Tibial and Antegrade Femoral Nailing System

K241651 · Zimmer, Inc. · Orthopedic
Sep 2024
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K241651 is an FDA 510(k) clearance for the Affixus Tibial and Antegrade Femoral Nailing System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 26, 2024, 111 days after receiving the submission on June 7, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K241651 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2024
Decision Date September 26, 2024
Days to Decision 111 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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