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FDA 510(k)

Solidex® Ti-Links and Screws

K-Number: K251515 · 2026-02-10

ApplicantCreoDent Hudson Valley
Decision Date2026-02-10
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Solidex® Ti-Links and Screws is a medical device manufactured by CreoDent Hudson Valley. It received FDA 510(k) clearance on 2026-02-10 under approval number K251515. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solidex® Ti-Links and Screws?

Solidex® Ti-Links and Screws is a medical device that received FDA 510(k) clearance on 2026-02-10. It is manufactured by CreoDent Hudson Valley. The 510(k) number is K251515.

When was Solidex® Ti-Links and Screws approved by the FDA?

Solidex® Ti-Links and Screws received FDA 510(k) clearance on 2026-02-10, under approval number K251515.

What company makes Solidex® Ti-Links and Screws?

Solidex® Ti-Links and Screws is manufactured by CreoDent Hudson Valley.

What is the FDA product code for Solidex® Ti-Links and Screws?

The FDA product code for Solidex® Ti-Links and Screws is NHA.

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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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