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FDA 510(k)

SIGNEX

K-Number: K243469 · 2025-05-29

ApplicantOsteonic Co., Ltd.
Decision Date2025-05-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIGNEX is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K243469. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNEX?

SIGNEX is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K243469.

When did SIGNEX receive FDA 510(k) clearance?

SIGNEX received FDA 510(k) clearance on 2025-05-29, under 510(k) number K243469.

Who is the listed applicant for SIGNEX?

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

What is the FDA product code for SIGNEX?

The FDA product code for SIGNEX is HRS.

Other records listing Osteonic Co., Ltd. as applicant

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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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