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FDA 510(k)

OSTEON II

K-Number: K112716 · 2012-01-17

ApplicantGenoss Co., Ltd.
Decision Date2012-01-17
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEON II 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 2012-01-17 under 510(k) number K112716. 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 II?

OSTEON II is a medical device that received FDA 510(k) clearance on 2012-01-17. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K112716.

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

OSTEON II received FDA 510(k) clearance on 2012-01-17, under 510(k) number K112716.

Who is the listed applicant for OSTEON II?

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 II?

The FDA product code for OSTEON II 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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