Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Talon DistalFix Humeral Nail

K-Number: K173255 · 2018-02-22

ApplicantOrthopedic Designs North America, Inc.
Decision Date2018-02-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Talon DistalFix Humeral Nail is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Designs North America, Inc.. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K173255. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Talon DistalFix Humeral Nail?

Talon DistalFix Humeral Nail is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Orthopedic Designs North America, Inc.. The 510(k) number is K173255.

When did Talon DistalFix Humeral Nail receive FDA 510(k) clearance?

Talon DistalFix Humeral Nail received FDA 510(k) clearance on 2018-02-22, under 510(k) number K173255.

Who is the listed applicant for Talon DistalFix Humeral Nail?

The FDA 510(k) record lists Orthopedic Designs North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Talon DistalFix Humeral Nail?

The FDA product code for Talon DistalFix Humeral Nail is HSB.

Other records listing Orthopedic Designs North America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210146Cannulated Compression Device System

Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑