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FDA 510(k)

OrthoFit

K-Number: K261129 · 2026-07-02

ApplicantSpident Co., Ltd.
Decision Date2026-07-02
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OrthoFit is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K261129. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoFit?

OrthoFit is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Spident Co., Ltd.. The 510(k) number is K261129.

When did OrthoFit receive FDA 510(k) clearance?

OrthoFit received FDA 510(k) clearance on 2026-07-02, under 510(k) number K261129.

Who is the listed applicant for OrthoFit?

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

What is the FDA product code for OrthoFit?

The FDA product code for OrthoFit is DYH.

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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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