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FDA 510(k)

TruBase S

K-Number: K201842 · 2021-06-04

ApplicantTruabutment, Inc.
Decision Date2021-06-04
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TruBase S is a medical device manufactured by Truabutment, Inc.. It received FDA 510(k) clearance on 2021-06-04 under approval number K201842. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TruBase S?

TruBase S is a medical device that received FDA 510(k) clearance on 2021-06-04. It is manufactured by Truabutment, Inc.. The 510(k) number is K201842.

When was TruBase S approved by the FDA?

TruBase S received FDA 510(k) clearance on 2021-06-04, under approval number K201842.

What company makes TruBase S?

TruBase S is manufactured by Truabutment, Inc..

What is the FDA product code for TruBase S?

The FDA product code for TruBase S is NHA.

Other Devices by Truabutment, Inc.

K171532TruBase S K172100URIS OMNI System K172304TruAbutment DS K200817URIS OMNI Narrow System & Prosthetic K191913TruAbutment DS K183106TruAbutment DS

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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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