SIGNEX
K-Number: K243469 · 2025-05-29
ApplicantOsteonic Co., Ltd.
Decision Date2025-05-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SIGNEX is a medical device manufactured by Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2025-05-29 under approval 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. It is manufactured by Osteonic Co., Ltd.. The 510(k) number is K243469.
When was SIGNEX approved by the FDA?
SIGNEX received FDA 510(k) clearance on 2025-05-29, under approval number K243469.
What company makes SIGNEX?
SIGNEX is manufactured by Osteonic Co., Ltd..
What is the FDA product code for SIGNEX?
The FDA product code for SIGNEX is HRS.
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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.