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FDA 510(k)

Dyflex-II

K-Number: K212700 · 2022-11-15

ApplicantTaeyeon Medical Co., Ltd.
Decision Date2022-11-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dyflex-II is a medical device manufactured by Taeyeon Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-11-15 under approval number K212700. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dyflex-II?

Dyflex-II is a medical device that received FDA 510(k) clearance on 2022-11-15. It is manufactured by Taeyeon Medical Co., Ltd.. The 510(k) number is K212700.

When was Dyflex-II approved by the FDA?

Dyflex-II received FDA 510(k) clearance on 2022-11-15, under approval number K212700.

What company makes Dyflex-II?

Dyflex-II is manufactured by Taeyeon Medical Co., Ltd..

What is the FDA product code for Dyflex-II?

The FDA product code for Dyflex-II is NKB.

Other Devices by Taeyeon Medical Co., Ltd.

K202027Balex bone Expander System

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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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