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FDA 510(k)

ET US SS Prosthetic system

K-Number: K160670 · 2017-04-25

ApplicantOsstem Implant Co., Ltd.
Decision Date2017-04-25
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ET US SS Prosthetic system is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2017-04-25 under approval number K160670. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ET US SS Prosthetic system?

ET US SS Prosthetic system is a medical device that received FDA 510(k) clearance on 2017-04-25. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K160670.

When was ET US SS Prosthetic system approved by the FDA?

ET US SS Prosthetic system received FDA 510(k) clearance on 2017-04-25, under approval number K160670.

What company makes ET US SS Prosthetic system?

ET US SS Prosthetic system is manufactured by Osstem Implant Co., Ltd..

What is the FDA product code for ET US SS Prosthetic system?

The FDA product code for ET US SS Prosthetic system is NHA.

Related Clinical Trials

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Other Devices by Osstem Implant Co., Ltd.

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Related Devices (Code: NHA)

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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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