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FDA 510(k)

REVERE STABILIZATION SYSTEM

K-Number: K093294 · 2010-02-17

ApplicantGlobus Medical, Inc.
Decision Date2010-02-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVERE 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 2010-02-17 under 510(k) number K093294. 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 REVERE STABILIZATION SYSTEM?

REVERE STABILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-17. The listed applicant is Globus Medical, Inc.. The 510(k) number is K093294.

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

REVERE STABILIZATION SYSTEM received FDA 510(k) clearance on 2010-02-17, under 510(k) number K093294.

Who is the listed applicant for REVERE 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 REVERE STABILIZATION SYSTEM?

The FDA product code for REVERE STABILIZATION SYSTEM is NKB.

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Related Devices (Code: 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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