FDA 510(k)

OSTEON III

K-Number: K153676 · 2016-09-14

Decision Date2016-09-14

Product CodeLYC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OSTEON III is a medical device manufactured by Genoss Co., Ltd.. It received FDA 510(k) clearance on 2016-09-14 under approval 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. It is manufactured by Genoss Co., Ltd.. The 510(k) number is K153676.

When was OSTEON III approved by the FDA?

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

What company makes OSTEON III?

OSTEON III is manufactured by Genoss Co., Ltd..

What is the FDA product code for OSTEON III?

The FDA product code for OSTEON III is LYC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.