ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
K-Number: K254010 · 2026-01-14
ApplicantBrainlab SE
Decision Date2026-01-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface is a medical device manufactured by Brainlab SE. It received FDA 510(k) clearance on 2026-01-14 under approval number K254010. 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 (2.0.2); ExacTrac Dynamic Surface?
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface is a medical device that received FDA 510(k) clearance on 2026-01-14. It is manufactured by Brainlab SE. The 510(k) number is K254010.
When was ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface approved by the FDA?
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface received FDA 510(k) clearance on 2026-01-14, under approval number K254010.
What company makes ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface is manufactured by Brainlab SE.
What is the FDA product code for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?
The FDA product code for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface 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.