Cleared Traditional

Shotel Ankle Arthrodesis Nail System

K163627 · Biopro, Inc. · Orthopedic
Sep 2017
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K163627 is an FDA 510(k) clearance for the Shotel Ankle Arthrodesis Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on September 14, 2017, 266 days after receiving the submission on December 22, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K163627 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2016
Decision Date September 14, 2017
Days to Decision 266 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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