Cleared Traditional

AUTOBAHN(R) EVO Femoral Nails

K220659 · Globus Medical, Inc. · Orthopedic
Sep 2022
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K220659 is an FDA 510(k) clearance for the AUTOBAHN(R) EVO Femoral Nails, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on September 9, 2022, 186 days after receiving the submission on March 7, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K220659 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2022
Decision Date September 09, 2022
Days to Decision 186 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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