Cleared Special

Affixus Hip Fracture Nail

K183162 · Biomet, Inc. · Orthopedic
Dec 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K183162 is an FDA 510(k) clearance for the Affixus Hip Fracture Nail, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 14, 2018, 29 days after receiving the submission on November 15, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K183162 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2018
Decision Date December 14, 2018
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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