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FDA 510(k)

Agile Nail

K-Number: K172699 · 2018-04-23

ApplicantOrthofix Srl
Decision Date2018-04-23
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Agile Nail is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2018-04-23 under 510(k) number K172699. 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 Agile Nail?

Agile Nail is a medical device that received FDA 510(k) clearance on 2018-04-23. The listed applicant is Orthofix Srl. The 510(k) number is K172699.

When did Agile Nail receive FDA 510(k) clearance?

Agile Nail received FDA 510(k) clearance on 2018-04-23, under 510(k) number K172699.

Who is the listed applicant for Agile Nail?

The FDA 510(k) record lists Orthofix Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Agile Nail?

The FDA product code for Agile Nail is HSB.

Other records listing Orthofix Srl as applicant

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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.

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