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FDA 510(k)

OSTEON III

K-Number: K153676 · 2016-09-14

ApplicantGenoss Co., Ltd.
Decision Date2016-09-14
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEON III is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K153676. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEON III?

OSTEON III is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K153676.

When did OSTEON III receive FDA 510(k) clearance?

OSTEON III received FDA 510(k) clearance on 2016-09-14, under 510(k) number K153676.

Who is the listed applicant for OSTEON III?

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

What is the FDA product code for OSTEON III?

The FDA product code for OSTEON III is LYC.

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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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