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FDA 510(k)

HG II FIXTURE SYSTEM

K-Number: K080744 · 2008-07-17

ApplicantOsstem Implant Co., Ltd.
Decision Date2008-07-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HG II FIXTURE 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 2008-07-17 under 510(k) number K080744. 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 HG II FIXTURE SYSTEM?

HG II FIXTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-17. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K080744.

When did HG II FIXTURE SYSTEM receive FDA 510(k) clearance?

HG II FIXTURE SYSTEM received FDA 510(k) clearance on 2008-07-17, under 510(k) number K080744.

Who is the listed applicant for HG II FIXTURE 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 HG II FIXTURE SYSTEM?

The FDA product code for HG II FIXTURE 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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