FDA 510(k)

PATRIOT® Lumbar Spacers, SUSTAIN® Spacers

K-Number: K181357 · 2018-12-06

Decision Date2018-12-06

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PATRIOT® Lumbar Spacers, SUSTAIN® Spacers is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2018-12-06 under approval number K181357. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATRIOT® Lumbar Spacers, SUSTAIN® Spacers?

PATRIOT® Lumbar Spacers, SUSTAIN® Spacers is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Globus Medical, Inc.. The 510(k) number is K181357.

When was PATRIOT® Lumbar Spacers, SUSTAIN® Spacers approved by the FDA?

PATRIOT® Lumbar Spacers, SUSTAIN® Spacers received FDA 510(k) clearance on 2018-12-06, under approval number K181357.

What company makes PATRIOT® Lumbar Spacers, SUSTAIN® Spacers?

PATRIOT® Lumbar Spacers, SUSTAIN® Spacers is manufactured by Globus Medical, Inc..

What is the FDA product code for PATRIOT® Lumbar Spacers, SUSTAIN® Spacers?

The FDA product code for PATRIOT® Lumbar Spacers, SUSTAIN® Spacers is MAX.

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: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.