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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 a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2024-08-22 under approval 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. It is manufactured by Paragon 28, Inc.. The 510(k) number is K234128.

When was Phantom Fibula Nail System approved by the FDA?

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

What company makes Phantom Fibula Nail System?

Phantom Fibula Nail System is manufactured by Paragon 28, Inc..

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

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

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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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