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FDA 510(k)

Phantom® Hindfoot TTC/TC Nail System

K-Number: K251850 · 2025-07-14

ApplicantParagon 28, Inc.
Decision Date2025-07-14
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 2025-07-14 under approval number K251850. 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 2025-07-14. It is manufactured by Paragon 28, Inc.. The 510(k) number is K251850.

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

Phantom® Hindfoot TTC/TC Nail System received FDA 510(k) clearance on 2025-07-14, under approval number K251850.

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.

Related Clinical Trials

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Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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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