Cleared Special

Affixus(R) Natural Nail(R) System Humeral Nail

K200814 · Zimmer GmbH · Orthopedic
Apr 2020
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K200814 is an FDA 510(k) clearance for the Affixus(R) Natural Nail(R) System Humeral Nail, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on April 28, 2020, 29 days after receiving the submission on March 30, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K200814 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2020
Decision Date April 28, 2020
Days to Decision 29 days
Submission Type Special
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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