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FDA 510(k)

INDEPENDENCE® Spacers

K-Number: K170157 · 2017-09-25

ApplicantGlobus Medical, Inc.
Decision Date2017-09-25
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INDEPENDENCE® Spacers is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2017-09-25 under approval number K170157. 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 INDEPENDENCE® Spacers?

INDEPENDENCE® Spacers is a medical device that received FDA 510(k) clearance on 2017-09-25. It is manufactured by Globus Medical, Inc.. The 510(k) number is K170157.

When was INDEPENDENCE® Spacers approved by the FDA?

INDEPENDENCE® Spacers received FDA 510(k) clearance on 2017-09-25, under approval number K170157.

What company makes INDEPENDENCE® Spacers?

INDEPENDENCE® Spacers is manufactured by Globus Medical, Inc..

What is the FDA product code for INDEPENDENCE® Spacers?

The FDA product code for INDEPENDENCE® Spacers is OVD.

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: 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. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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