Cleared Traditional

DePuy Synthes Retrograde Femoral Nail Advanced System

K233696 · DePuy Synthes · Orthopedic
Aug 2024
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K233696 is an FDA 510(k) clearance for the DePuy Synthes Retrograde Femoral Nail Advanced System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by DePuy Synthes (19380, US). The FDA issued a Cleared decision on August 1, 2024, 258 days after receiving the submission on November 17, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K233696 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2023
Decision Date August 01, 2024
Days to Decision 258 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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