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FDA 510(k)

SS SA Fixture

K-Number: K163557 · 2017-05-15

ApplicantOsstem Implant Co., Ltd.
Decision Date2017-05-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SS SA Fixture 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 2017-05-15 under 510(k) number K163557. 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 SS SA Fixture?

SS SA Fixture is a medical device that received FDA 510(k) clearance on 2017-05-15. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K163557.

When did SS SA Fixture receive FDA 510(k) clearance?

SS SA Fixture received FDA 510(k) clearance on 2017-05-15, under 510(k) number K163557.

Who is the listed applicant for SS SA Fixture?

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 SS SA Fixture?

The FDA product code for SS SA Fixture is 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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