US SA Implant System
K-Number: K161103 · 2017-02-02
ApplicantOsstem Implant Co., Ltd.
Decision Date2017-02-02
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
US SA Implant System is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2017-02-02 under approval number K161103. 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 SA Implant System?
US SA Implant System is a medical device that received FDA 510(k) clearance on 2017-02-02. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K161103.
When was US SA Implant System approved by the FDA?
US SA Implant System received FDA 510(k) clearance on 2017-02-02, under approval number K161103.
What company makes US SA Implant System?
US SA Implant System is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for US SA Implant System?
The FDA product code for US SA Implant System 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.