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FDA 510(k)

BEACON STABILIZATION SYSTEM

K-Number: K121922 · 2012-07-26

ApplicantGlobus Medical, Inc.
Decision Date2012-07-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BEACON STABILIZATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2012-07-26 under 510(k) number K121922. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEACON STABILIZATION SYSTEM?

BEACON STABILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Globus Medical, Inc.. The 510(k) number is K121922.

When did BEACON STABILIZATION SYSTEM receive FDA 510(k) clearance?

BEACON STABILIZATION SYSTEM received FDA 510(k) clearance on 2012-07-26, under 510(k) number K121922.

Who is the listed applicant for BEACON STABILIZATION SYSTEM?

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

What is the FDA product code for BEACON STABILIZATION SYSTEM?

The FDA product code for BEACON STABILIZATION SYSTEM is NKB.

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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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