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FDA 510(k)

DASH KNEE

K-Number: K102251 · 2011-05-17

ApplicantBrainlab AG
Decision Date2011-05-17
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DASH KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2011-05-17 under 510(k) number K102251. 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 DASH KNEE?

DASH KNEE is a medical device that received FDA 510(k) clearance on 2011-05-17. The listed applicant is Brainlab AG. The 510(k) number is K102251.

When did DASH KNEE receive FDA 510(k) clearance?

DASH KNEE received FDA 510(k) clearance on 2011-05-17, under 510(k) number K102251.

Who is the listed applicant for DASH KNEE?

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 DASH KNEE?

The FDA product code for DASH KNEE 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.

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