FDA 510(k)

BRAINLAB KNEE ARTHROSCOPY

K-Number: K093118 · 2010-06-11

Decision Date2010-06-11

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BRAINLAB KNEE ARTHROSCOPY is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2010-06-11 under 510(k) number K093118. 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 KNEE ARTHROSCOPY?

BRAINLAB KNEE ARTHROSCOPY is a medical device that received FDA 510(k) clearance on 2010-06-11. The listed applicant is Brainlab AG. The 510(k) number is K093118.

When did BRAINLAB KNEE ARTHROSCOPY receive FDA 510(k) clearance?

BRAINLAB KNEE ARTHROSCOPY received FDA 510(k) clearance on 2010-06-11, under 510(k) number K093118.

Who is the listed applicant for BRAINLAB KNEE ARTHROSCOPY?

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 KNEE ARTHROSCOPY?

The FDA product code for BRAINLAB KNEE ARTHROSCOPY 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.