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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 the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) 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. The listed applicant is Globus Medical, Inc.. The 510(k) number is K161223.

When did TransContinental® M Spacers and InterContinental® Plate-Spacers receive FDA 510(k) clearance?

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

Who is the listed applicant for TransContinental® M Spacers and InterContinental® Plate-Spacers?

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 TransContinental® M Spacers and InterContinental® Plate-Spacers?

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