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FDA 510(k)

Dr.AlignNavi

K-Number: K262378 · 2026-10-07

ApplicantInnoDtech, Inc.
Decision Date2026-10-07
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dr.AlignNavi is the device name listed in this FDA 510(k) record. The listed applicant is InnoDtech, Inc.. It received FDA 510(k) clearance on 2026-10-07 under 510(k) number K262378. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dr.AlignNavi?

Dr.AlignNavi is a medical device that received FDA 510(k) clearance on 2026-10-07. The listed applicant is InnoDtech, Inc.. The 510(k) number is K262378.

When did Dr.AlignNavi receive FDA 510(k) clearance?

Dr.AlignNavi received FDA 510(k) clearance on 2026-10-07, under 510(k) number K262378.

Who is the listed applicant for Dr.AlignNavi?

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

What is the FDA product code for Dr.AlignNavi?

The FDA product code for Dr.AlignNavi is PNN.

Related Clinical Trials

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.

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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.

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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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