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FDA 510(k)

COALITION Spacers

K-Number: K151939 · 2016-01-29

ApplicantGlobus Medical, Inc.
Decision Date2016-01-29
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COALITION Spacers is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-01-29 under approval number K151939. 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 Spacers?

COALITION Spacers is a medical device that received FDA 510(k) clearance on 2016-01-29. It is manufactured by Globus Medical, Inc.. The 510(k) number is K151939.

When was COALITION Spacers approved by the FDA?

COALITION Spacers received FDA 510(k) clearance on 2016-01-29, under approval number K151939.

What company makes COALITION Spacers?

COALITION Spacers is manufactured by Globus Medical, Inc..

What is the FDA product code for COALITION Spacers?

The FDA product code for COALITION Spacers is OVE.

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: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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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