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FDA 510(k)

Phantom Small Bone Intramedullary Nail System

K-Number: K170693 · 2017-06-19

ApplicantParagon 28, Inc.
Decision Date2017-06-19
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Phantom Small Bone Intramedullary Nail System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2017-06-19 under approval number K170693. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phantom Small Bone Intramedullary Nail System?

Phantom Small Bone Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2017-06-19. It is manufactured by Paragon 28, Inc.. The 510(k) number is K170693.

When was Phantom Small Bone Intramedullary Nail System approved by the FDA?

Phantom Small Bone Intramedullary Nail System received FDA 510(k) clearance on 2017-06-19, under approval number K170693.

What company makes Phantom Small Bone Intramedullary Nail System?

Phantom Small Bone Intramedullary Nail System is manufactured by Paragon 28, Inc..

What is the FDA product code for Phantom Small Bone Intramedullary Nail System?

The FDA product code for Phantom Small Bone Intramedullary Nail System is KTW.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Paragon 28, Inc.

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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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