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 a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-03-13 under approval 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. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K183026.
When was Wright Jones Fracture System approved by the FDA?
Wright Jones Fracture System received FDA 510(k) clearance on 2019-03-13, under approval number K183026.
What company makes Wright Jones Fracture System?
Wright Jones Fracture System is manufactured by Wrightmedicaltechnologyinc.
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.