ExacTrac Dynamic 1.1.2
K-Number: K231052 · 2023-05-11
ApplicantBrainlab AG
Decision Date2023-05-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ExacTrac Dynamic 1.1.2 is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2023-05-11 under approval number K231052. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ExacTrac Dynamic 1.1.2?
ExacTrac Dynamic 1.1.2 is a medical device that received FDA 510(k) clearance on 2023-05-11. It is manufactured by Brainlab AG. The 510(k) number is K231052.
When was ExacTrac Dynamic 1.1.2 approved by the FDA?
ExacTrac Dynamic 1.1.2 received FDA 510(k) clearance on 2023-05-11, under approval number K231052.
What company makes ExacTrac Dynamic 1.1.2?
ExacTrac Dynamic 1.1.2 is manufactured by Brainlab AG.
What is the FDA product code for ExacTrac Dynamic 1.1.2?
The FDA product code for ExacTrac Dynamic 1.1.2 is IYE.
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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.