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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 the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2017-06-19 under 510(k) 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. The listed applicant is Paragon 28, Inc.. The 510(k) number is K170693.

When did Phantom Small Bone Intramedullary Nail System receive FDA 510(k) clearance?

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

Who is the listed applicant for Phantom Small Bone Intramedullary 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 Small Bone Intramedullary Nail System?

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

Related Clinical Trials

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NCT07569575Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone FracturesNOT_YET_RECRUITING

Other records listing Paragon 28, Inc. as applicant

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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Related Devices (Code: KTW)

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.

K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos)K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc.

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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