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FDA 510(k)

INTERCONTINENTAL PLATE-SPACER

K-Number: K103382 · 2011-05-20

ApplicantGlobus Medical, Inc.
Decision Date2011-05-20
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERCONTINENTAL PLATE-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 2011-05-20 under 510(k) number K103382. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERCONTINENTAL PLATE-SPACER?

INTERCONTINENTAL PLATE-SPACER is a medical device that received FDA 510(k) clearance on 2011-05-20. The listed applicant is Globus Medical, Inc.. The 510(k) number is K103382.

When did INTERCONTINENTAL PLATE-SPACER receive FDA 510(k) clearance?

INTERCONTINENTAL PLATE-SPACER received FDA 510(k) clearance on 2011-05-20, under 510(k) number K103382.

Who is the listed applicant for INTERCONTINENTAL PLATE-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 INTERCONTINENTAL PLATE-SPACER?

The FDA product code for INTERCONTINENTAL PLATE-SPACER is OVD.

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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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