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FDA 510(k)

COALITION SPACER

K-Number: K083389 · 2009-03-26

ApplicantGlobus Medical, Inc.
Decision Date2009-03-26
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COALITION 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 2009-03-26 under 510(k) number K083389. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COALITION SPACER?

COALITION SPACER is a medical device that received FDA 510(k) clearance on 2009-03-26. The listed applicant is Globus Medical, Inc.. The 510(k) number is K083389.

When did COALITION SPACER receive FDA 510(k) clearance?

COALITION SPACER received FDA 510(k) clearance on 2009-03-26, under 510(k) number K083389.

Who is the listed applicant for COALITION 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 COALITION SPACER?

The FDA product code for COALITION SPACER is OVE.

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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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