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FDA 510(k)

TransContinental® M Spacers and InterContinental® Plate-Spacers

K-Number: K161223 · 2016-07-15

ApplicantGlobus Medical, Inc.
Decision Date2016-07-15
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TransContinental® M Spacers and InterContinental® Plate-Spacers is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-07-15 under approval number K161223. 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 TransContinental® M Spacers and InterContinental® Plate-Spacers?

TransContinental® M Spacers and InterContinental® Plate-Spacers is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Globus Medical, Inc.. The 510(k) number is K161223.

When was TransContinental® M Spacers and InterContinental® Plate-Spacers approved by the FDA?

TransContinental® M Spacers and InterContinental® Plate-Spacers received FDA 510(k) clearance on 2016-07-15, under approval number K161223.

What company makes TransContinental® M Spacers and InterContinental® Plate-Spacers?

TransContinental® M Spacers and InterContinental® Plate-Spacers is manufactured by Globus Medical, Inc..

What is the FDA product code for TransContinental® M Spacers and InterContinental® Plate-Spacers?

The FDA product code for TransContinental® M Spacers and InterContinental® Plate-Spacers is OVD.

Other Devices by Globus Medical, Inc.

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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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