FDA 510(k)

BRAINLAB TRAUMA

K-Number: K110204 · 2011-08-05

Decision Date2011-08-05

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BRAINLAB TRAUMA is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2011-08-05 under 510(k) number K110204. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINLAB TRAUMA?

BRAINLAB TRAUMA is a medical device that received FDA 510(k) clearance on 2011-08-05. The listed applicant is Brainlab AG. The 510(k) number is K110204.

When did BRAINLAB TRAUMA receive FDA 510(k) clearance?

BRAINLAB TRAUMA received FDA 510(k) clearance on 2011-08-05, under 510(k) number K110204.

Who is the listed applicant for BRAINLAB TRAUMA?

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 BRAINLAB TRAUMA?

The FDA product code for BRAINLAB TRAUMA is OLO.

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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.