Cleared Traditional

Tornier Humeral Nail and Tornier Long Humeral Nail

K230352 · Tornier, Inc. · Orthopedic
Oct 2023
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K230352 is an FDA 510(k) clearance for the Tornier Humeral Nail and Tornier Long Humeral Nail, 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 October 31, 2023, 264 days after receiving the submission on February 9, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K230352 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2023
Decision Date October 31, 2023
Days to Decision 264 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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