Cleared Special

AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT

K133376 · Tornier, Inc. · Orthopedic
Dec 2013
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K133376 is an FDA 510(k) clearance for the AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 5, 2013, 31 days after receiving the submission on November 4, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K133376 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2013
Decision Date December 05, 2013
Days to Decision 31 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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