T2
K-Number: K212303 · 2021-09-21
ApplicantOsstem Implant Co., Ltd.
Decision Date2021-09-21
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
T2 is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2021-09-21 under approval number K212303. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the T2?
T2 is a medical device that received FDA 510(k) clearance on 2021-09-21. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K212303.
When was T2 approved by the FDA?
T2 received FDA 510(k) clearance on 2021-09-21, under approval number K212303.
What company makes T2?
T2 is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for T2?
The FDA product code for T2 is OAS.
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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.