ST Internal Fixture System
K-Number: K152787 · 2016-07-22
ApplicantT-Plus Implant Tech. Co., Ltd.
Decision Date2016-07-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ST Internal Fixture System is a medical device manufactured by T-Plus Implant Tech. Co., Ltd.. It received FDA 510(k) clearance on 2016-07-22 under approval number K152787. 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 ST Internal Fixture System?
ST Internal Fixture System is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by T-Plus Implant Tech. Co., Ltd.. The 510(k) number is K152787.
When was ST Internal Fixture System approved by the FDA?
ST Internal Fixture System received FDA 510(k) clearance on 2016-07-22, under approval number K152787.
What company makes ST Internal Fixture System?
ST Internal Fixture System is manufactured by T-Plus Implant Tech. Co., Ltd..
What is the FDA product code for ST Internal Fixture System?
The FDA product code for ST Internal Fixture 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.