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FDA 510(k)

RETAIN RADIOLUCENT SPACER

K-Number: K061380 · 2006-06-08

ApplicantGlobus Medical, Inc.
Decision Date2006-06-08
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RETAIN RADIOLUCENT SPACER 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 2006-06-08 under 510(k) number K061380. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETAIN RADIOLUCENT SPACER?

RETAIN RADIOLUCENT SPACER is a medical device that received FDA 510(k) clearance on 2006-06-08. The listed applicant is Globus Medical, Inc.. The 510(k) number is K061380.

When did RETAIN RADIOLUCENT SPACER receive FDA 510(k) clearance?

RETAIN RADIOLUCENT SPACER received FDA 510(k) clearance on 2006-06-08, under 510(k) number K061380.

Who is the listed applicant for RETAIN RADIOLUCENT SPACER?

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 RETAIN RADIOLUCENT SPACER?

The FDA product code for RETAIN RADIOLUCENT SPACER is MQP.

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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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