Cleared Traditional

DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

K201346 · Synthes USA Products, LLC · Orthopedic
Sep 2020
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K201346 is an FDA 510(k) clearance for the DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Synthes USA Products, LLC (19380, US). The FDA issued a Cleared decision on September 23, 2020, 125 days after receiving the submission on May 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K201346 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2020
Decision Date September 23, 2020
Days to Decision 125 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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