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FDA 510(k)

BIOGENESIS IMPLANT SYSTEM

K-Number: K120089 · 2013-03-13

ApplicantBiogenesis Co., Ltd.
Decision Date2013-03-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOGENESIS IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biogenesis Co., Ltd.. It received FDA 510(k) clearance on 2013-03-13 under 510(k) number K120089. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGENESIS IMPLANT SYSTEM?

BIOGENESIS IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-13. The listed applicant is Biogenesis Co., Ltd.. The 510(k) number is K120089.

When did BIOGENESIS IMPLANT SYSTEM receive FDA 510(k) clearance?

BIOGENESIS IMPLANT SYSTEM received FDA 510(k) clearance on 2013-03-13, under 510(k) number K120089.

Who is the listed applicant for BIOGENESIS IMPLANT SYSTEM?

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

What is the FDA product code for BIOGENESIS IMPLANT SYSTEM?

The FDA product code for BIOGENESIS IMPLANT SYSTEM is DZE.

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Related Devices (Code: DZE)

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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.

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