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FDA 510(k)

OSTEON, OSTEON SINUS, OSTEON LIFTING

K-Number: K102015 · 2010-11-19

ApplicantGenoss Co., Ltd.
Decision Date2010-11-19
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEON, OSTEON SINUS, OSTEON LIFTING 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 2010-11-19 under 510(k) number K102015. 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, OSTEON SINUS, OSTEON LIFTING?

OSTEON, OSTEON SINUS, OSTEON LIFTING is a medical device that received FDA 510(k) clearance on 2010-11-19. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K102015.

When did OSTEON, OSTEON SINUS, OSTEON LIFTING receive FDA 510(k) clearance?

OSTEON, OSTEON SINUS, OSTEON LIFTING received FDA 510(k) clearance on 2010-11-19, under 510(k) number K102015.

Who is the listed applicant for OSTEON, OSTEON SINUS, OSTEON LIFTING?

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, OSTEON SINUS, OSTEON LIFTING?

The FDA product code for OSTEON, OSTEON SINUS, OSTEON LIFTING 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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