FDA 510(k)

DynaFlex

K-Number: K190583 · 2019-06-27

Decision Date2019-06-27

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DynaFlex is the device name listed in this FDA 510(k) record. The listed applicant is Dyna Flex. It received FDA 510(k) clearance on 2019-06-27 under 510(k) number K190583. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DynaFlex?

DynaFlex is a medical device that received FDA 510(k) clearance on 2019-06-27. The listed applicant is Dyna Flex. The 510(k) number is K190583.

When did DynaFlex receive FDA 510(k) clearance?

DynaFlex received FDA 510(k) clearance on 2019-06-27, under 510(k) number K190583.

Who is the listed applicant for DynaFlex?

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

What is the FDA product code for DynaFlex?

The FDA product code for DynaFlex is NXC.

Other records listing Dyna Flex 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.

K230225DynaFlex Clear Brackets & Buttons

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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.