TruAbutment DS
K-Number: K191913 · 2020-06-19
ApplicantTruabutment, Inc.
Decision Date2020-06-19
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TruAbutment DS is a medical device manufactured by Truabutment, Inc.. It received FDA 510(k) clearance on 2020-06-19 under approval number K191913. 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?
TruAbutment DS is a medical device that received FDA 510(k) clearance on 2020-06-19. It is manufactured by Truabutment, Inc.. The 510(k) number is K191913.
When was TruAbutment DS approved by the FDA?
TruAbutment DS received FDA 510(k) clearance on 2020-06-19, under approval number K191913.
What company makes TruAbutment DS?
TruAbutment DS is manufactured by Truabutment, Inc..
What is the FDA product code for TruAbutment DS?
The FDA product code for TruAbutment DS 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.