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FDA 510(k)

Phantom® Hindfoot TTC/TC Nail System

K-Number: K201227 · 2020-07-17

ApplicantParagon 28, Inc.
Decision Date2020-07-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Phantom® Hindfoot TTC/TC Nail System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2020-07-17 under approval number K201227. 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 2020-07-17. It is manufactured by Paragon 28, Inc.. The 510(k) number is K201227.

When was Phantom® Hindfoot TTC/TC Nail System approved by the FDA?

Phantom® Hindfoot TTC/TC Nail System received FDA 510(k) clearance on 2020-07-17, under approval number K201227.

What company makes Phantom® Hindfoot TTC/TC Nail System?

Phantom® Hindfoot TTC/TC Nail System is manufactured by Paragon 28, Inc..

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)

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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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