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FDA 510(k)

EXACTRAC VERO

K-Number: K122451 · 2012-09-28

ApplicantBrainlab AG
Decision Date2012-09-28
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXACTRAC VERO is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2012-09-28 under 510(k) number K122451. 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 VERO?

EXACTRAC VERO is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Brainlab AG. The 510(k) number is K122451.

When did EXACTRAC VERO receive FDA 510(k) clearance?

EXACTRAC VERO received FDA 510(k) clearance on 2012-09-28, under 510(k) number K122451.

Who is the listed applicant for EXACTRAC VERO?

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXACTRAC VERO?

The FDA product code for EXACTRAC VERO is IYE.

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Related Devices (Code: 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.

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