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FDA 510(k)

Wright Jones Fracture System

K-Number: K183026 · 2019-03-13

ApplicantWrightmedicaltechnologyinc
Decision Date2019-03-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Wright Jones Fracture System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K183026. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wright Jones Fracture System?

Wright Jones Fracture System is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K183026.

When did Wright Jones Fracture System receive FDA 510(k) clearance?

Wright Jones Fracture System received FDA 510(k) clearance on 2019-03-13, under 510(k) number K183026.

Who is the listed applicant for Wright Jones Fracture System?

The FDA 510(k) record lists Wrightmedicaltechnologyinc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wright Jones Fracture System?

The FDA product code for Wright Jones Fracture System is HWC. This falls under the Cardiovascular category.

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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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