Cleared Traditional

Zimmer? Natural Nail? System Cephalomedullary Nails; Affixus? Natural Nail? Humeral Nail System

K231114 · Zimmer Switzerland Manufacturing GmbH · Orthopedic

Aug 2023

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K231114 is an FDA 510(k) clearance for the Zimmer? Natural Nail? System Cephalomedullary Nails; Affixus? Natural Nail? Humeral Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Zimmer Switzerland Manufacturing GmbH (Winterthur, CH). The FDA issued a Cleared decision on August 9, 2023, 112 days after receiving the submission on April 19, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K231114 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2023
Decision Date	August 09, 2023
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF