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FDA 510(k)

ELSA Spacers

K-Number: K161379 · 2016-09-29

ApplicantGlobus Medical, Inc.
Decision Date2016-09-29
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELSA Spacers is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-09-29 under approval number K161379. 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 ELSA Spacers?

ELSA Spacers is a medical device that received FDA 510(k) clearance on 2016-09-29. It is manufactured by Globus Medical, Inc.. The 510(k) number is K161379.

When was ELSA Spacers approved by the FDA?

ELSA Spacers received FDA 510(k) clearance on 2016-09-29, under approval number K161379.

What company makes ELSA Spacers?

ELSA Spacers is manufactured by Globus Medical, Inc..

What is the FDA product code for ELSA Spacers?

The FDA product code for ELSA Spacers is OVD.

Other Devices by Globus Medical, Inc.

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 K153203Navigation Instruments

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc. K160597INDEPENDENCE MIS SpacersGlobus Medical, 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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