Talon DistalFix Humeral Nail

FDA 510(k) K173255 · Orthopedic Designs North America, Inc.

Substantially Equivalent

510(k) numberK173255

Submission

Device name
Talon DistalFix Humeral Nail
Applicant
Orthopedic Designs North America, Inc.
Tampa, FL, US
Received
October 10, 2017
Decision date
February 22, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

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K252016Arthrex Humeral NailsHSB · Traditional Arthrex, Inc.03/20/2026SE
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More from Fusion Orthopedics USA, LLC

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K210146Cannulated Compression Device SystemHWC · Traditional 04/13/2022SE
K152295Talon DistalFix Antegrade/Retrograde Femoral NailHSB · Traditional 11/03/2015SE
K111352Talon Distalfix Proximal Femoral NailHSB · Abbreviated 08/22/2011SE

Questions and answers

When was Talon DistalFix Humeral Nail cleared by the FDA?

Talon DistalFix Humeral Nail (K173255) received a 510(k) decision of Substantially Equivalent on February 22, 2018, 135 days after the submission was received.

What is the product code of K173255?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.