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FDA 510(k)

T1-CS, T1-C

K-Number: K183475 · 2019-08-30

ApplicantOsstem Implant Co., Ltd.
Decision Date2019-08-30
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

T1-CS, T1-C 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 2019-08-30 under 510(k) 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. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K183475.

When did T1-CS, T1-C receive FDA 510(k) clearance?

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

Who is the listed applicant for T1-CS, T1-C?

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 T1-CS, T1-C?

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

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