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FDA 510(k)

Brainlab Compatible K2M Navigation Instruments

K-Number: K192911 · 2019-11-14

ApplicantK2m, Inc.
Decision Date2019-11-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Brainlab Compatible K2M Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2019-11-14 under 510(k) number K192911. 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 Compatible K2M Navigation Instruments?

Brainlab Compatible K2M Navigation Instruments is a medical device that received FDA 510(k) clearance on 2019-11-14. The listed applicant is K2m, Inc.. The 510(k) number is K192911.

When did Brainlab Compatible K2M Navigation Instruments receive FDA 510(k) clearance?

Brainlab Compatible K2M Navigation Instruments received FDA 510(k) clearance on 2019-11-14, under 510(k) number K192911.

Who is the listed applicant for Brainlab Compatible K2M Navigation Instruments?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brainlab Compatible K2M Navigation Instruments?

The FDA product code for Brainlab Compatible K2M Navigation Instruments is OLO.

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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