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FDA 510(k)

FORTIFY Corpectomy Spacers

K-Number: K162315 · 2017-11-09

ApplicantGlobus Medical, Inc.
Decision Date2017-11-09
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FORTIFY Corpectomy Spacers is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2017-11-09 under approval number K162315. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTIFY Corpectomy Spacers?

FORTIFY Corpectomy Spacers is a medical device that received FDA 510(k) clearance on 2017-11-09. It is manufactured by Globus Medical, Inc.. The 510(k) number is K162315.

When was FORTIFY Corpectomy Spacers approved by the FDA?

FORTIFY Corpectomy Spacers received FDA 510(k) clearance on 2017-11-09, under approval number K162315.

What company makes FORTIFY Corpectomy Spacers?

FORTIFY Corpectomy Spacers is manufactured by Globus Medical, Inc..

What is the FDA product code for FORTIFY Corpectomy Spacers?

The FDA product code for FORTIFY Corpectomy Spacers is MQP.

Other Devices by Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

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Related Devices (Code: MQP)

K172330Blustone Synergy Silica SystemBlustone Synergy K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek K172323Omnia Medical VBROmnia Medical, LLC K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine K171704CAPRI Corpectomy Cage SystemK2m K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.

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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