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FDA 510(k)

ZYFUSE FACET FIXATION SYSTEM

K-Number: K090952 · 2009-07-14

ApplicantGlobus Medical, Inc.
Decision Date2009-07-14
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

ZYFUSE FACET FIXATION 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 2009-07-14 under 510(k) number K090952. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYFUSE FACET FIXATION SYSTEM?

ZYFUSE FACET FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-14. The listed applicant is Globus Medical, Inc.. The 510(k) number is K090952.

When did ZYFUSE FACET FIXATION SYSTEM receive FDA 510(k) clearance?

ZYFUSE FACET FIXATION SYSTEM received FDA 510(k) clearance on 2009-07-14, under 510(k) number K090952.

Who is the listed applicant for ZYFUSE FACET FIXATION 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 ZYFUSE FACET FIXATION SYSTEM?

The FDA product code for ZYFUSE FACET FIXATION SYSTEM is MRW.

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Related Devices (Code: MRW)

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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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