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FDA 510(k)

REVLOK FENESTRATED SCREW SYSTEM

K-Number: K110280 · 2011-07-06

ApplicantGlobus Medical, Inc.
Decision Date2011-07-06
Product CodeNKB
Advisory CommitteeOR
DecisionUnknown

Device Summary

REVLOK FENESTRATED SCREW 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 2011-07-06 under 510(k) number K110280. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the REVLOK FENESTRATED SCREW SYSTEM?

REVLOK FENESTRATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-06. The listed applicant is Globus Medical, Inc.. The 510(k) number is K110280.

When did REVLOK FENESTRATED SCREW SYSTEM receive FDA 510(k) clearance?

REVLOK FENESTRATED SCREW SYSTEM received FDA 510(k) clearance on 2011-07-06, under 510(k) number K110280.

Who is the listed applicant for REVLOK FENESTRATED SCREW 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 REVLOK FENESTRATED SCREW SYSTEM?

The FDA product code for REVLOK FENESTRATED SCREW 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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