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FDA 510(k)

Phantom® Hindfoot TTC/TC Nail System

K-Number: K253591 · 2026-03-05

ApplicantParagon 28, Inc.
Decision Date2026-03-05
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Phantom® Hindfoot TTC/TC 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 2026-03-05 under 510(k) number K253591. 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® Hindfoot TTC/TC Nail System?

Phantom® Hindfoot TTC/TC Nail System is a medical device that received FDA 510(k) clearance on 2026-03-05. The listed applicant is Paragon 28, Inc.. The 510(k) number is K253591.

When did Phantom® Hindfoot TTC/TC Nail System receive FDA 510(k) clearance?

Phantom® Hindfoot TTC/TC Nail System received FDA 510(k) clearance on 2026-03-05, under 510(k) number K253591.

Who is the listed applicant for Phantom® Hindfoot TTC/TC 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® Hindfoot TTC/TC Nail System?

The FDA product code for Phantom® Hindfoot TTC/TC Nail System is HSB.

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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.

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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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