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FDA 510(k)

Phantom Fibula Nail System

K-Number: K234128 · 2024-08-22

ApplicantParagon 28, Inc.
Decision Date2024-08-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Phantom Fibula Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K234128. 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 Phantom Fibula Nail System?

Phantom Fibula Nail System is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Paragon 28, Inc.. The 510(k) number is K234128.

When did Phantom Fibula Nail System receive FDA 510(k) clearance?

Phantom Fibula Nail System received FDA 510(k) clearance on 2024-08-22, under 510(k) number K234128.

Who is the listed applicant for Phantom Fibula Nail System?

The FDA 510(k) record lists Paragon 28, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phantom Fibula Nail System?

The FDA product code for Phantom Fibula Nail System is HSB.

Other records listing Paragon 28, Inc. 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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