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FDA 510(k)

dynaMX Intramedullary Implant

K-Number: K170326 · 2017-07-20

ApplicantArthrex, Inc.
Decision Date2017-07-20
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

dynaMX Intramedullary Implant is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2017-07-20 under approval number K170326. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the dynaMX Intramedullary Implant?

dynaMX Intramedullary Implant is a medical device that received FDA 510(k) clearance on 2017-07-20. It is manufactured by Arthrex, Inc.. The 510(k) number is K170326.

When was dynaMX Intramedullary Implant approved by the FDA?

dynaMX Intramedullary Implant received FDA 510(k) clearance on 2017-07-20, under approval number K170326.

What company makes dynaMX Intramedullary Implant?

dynaMX Intramedullary Implant is manufactured by Arthrex, Inc..

What is the FDA product code for dynaMX Intramedullary Implant?

The FDA product code for dynaMX Intramedullary Implant is HTY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.