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FDA 510(k)

MODIFICATION TO:MICROFUSE BONE VOID FILLER

K-Number: K083232 · 2008-12-24

ApplicantGlobus Medical, Inc.
Decision Date2008-12-24
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:MICROFUSE BONE VOID FILLER 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 2008-12-24 under 510(k) number K083232. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO:MICROFUSE BONE VOID FILLER?

MODIFICATION TO:MICROFUSE BONE VOID FILLER is a medical device that received FDA 510(k) clearance on 2008-12-24. The listed applicant is Globus Medical, Inc.. The 510(k) number is K083232.

When did MODIFICATION TO:MICROFUSE BONE VOID FILLER receive FDA 510(k) clearance?

MODIFICATION TO:MICROFUSE BONE VOID FILLER received FDA 510(k) clearance on 2008-12-24, under 510(k) number K083232.

Who is the listed applicant for MODIFICATION TO:MICROFUSE BONE VOID FILLER?

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 MODIFICATION TO:MICROFUSE BONE VOID FILLER?

The FDA product code for MODIFICATION TO:MICROFUSE BONE VOID FILLER is MQV.

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Related Devices (Code: MQV)

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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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