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FDA 510(k)

US/SS/GS SYSTEM

K-Number: K073247 · 2008-03-07

ApplicantOsstem Implant Co., Ltd.
Decision Date2008-03-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

US/SS/GS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2008-03-07 under 510(k) number K073247. 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 US/SS/GS SYSTEM?

US/SS/GS SYSTEM is a medical device that received FDA 510(k) clearance on 2008-03-07. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K073247.

When did US/SS/GS SYSTEM receive FDA 510(k) clearance?

US/SS/GS SYSTEM received FDA 510(k) clearance on 2008-03-07, under 510(k) number K073247.

Who is the listed applicant for US/SS/GS SYSTEM?

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

What is the FDA product code for US/SS/GS SYSTEM?

The FDA product code for US/SS/GS SYSTEM is DZE.

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Related Devices (Code: DZE)

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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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