TruAbutment DS, TruBase S
K-Number: K201197 · 2021-03-26
ApplicantTruabutment, Inc.
Decision Date2021-03-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TruAbutment DS, TruBase S is a medical device manufactured by Truabutment, Inc.. It received FDA 510(k) clearance on 2021-03-26 under approval number K201197. 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 TruAbutment DS, TruBase S?
TruAbutment DS, TruBase S is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Truabutment, Inc.. The 510(k) number is K201197.
When was TruAbutment DS, TruBase S approved by the FDA?
TruAbutment DS, TruBase S received FDA 510(k) clearance on 2021-03-26, under approval number K201197.
What company makes TruAbutment DS, TruBase S?
TruAbutment DS, TruBase S is manufactured by Truabutment, Inc..
What is the FDA product code for TruAbutment DS, TruBase S?
The FDA product code for TruAbutment DS, TruBase S is NHA.
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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.