FDA 510(k)

T1-CS, T1-C

K-Number: K183475 · 2019-08-30

Decision Date2019-08-30

Product CodeOAS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

T1-CS, T1-C is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-08-30 under approval number K183475. 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 T1-CS, T1-C?

T1-CS, T1-C is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K183475.

When was T1-CS, T1-C approved by the FDA?

T1-CS, T1-C received FDA 510(k) clearance on 2019-08-30, under approval number K183475.

What company makes T1-CS, T1-C?

T1-CS, T1-C is manufactured by Osstem Implant Co., Ltd..

What is the FDA product code for T1-CS, T1-C?

The FDA product code for T1-CS, T1-C is OAS.

Other Devices by Osstem Implant Co., Ltd.

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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.