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FDA 510(k)

Lumbar Expandable lnterbody Spacers -Additional Indications/Implants

K-Number: K221894 · 2023-08-03

ApplicantGlobus Medical, Inc.
Decision Date2023-08-03
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Lumbar Expandable lnterbody Spacers -Additional Indications/Implants is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2023-08-03 under approval number K221894. 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 Lumbar Expandable lnterbody Spacers -Additional Indications/Implants?

Lumbar Expandable lnterbody Spacers -Additional Indications/Implants is a medical device that received FDA 510(k) clearance on 2023-08-03. It is manufactured by Globus Medical, Inc.. The 510(k) number is K221894.

When was Lumbar Expandable lnterbody Spacers -Additional Indications/Implants approved by the FDA?

Lumbar Expandable lnterbody Spacers -Additional Indications/Implants received FDA 510(k) clearance on 2023-08-03, under approval number K221894.

What company makes Lumbar Expandable lnterbody Spacers -Additional Indications/Implants?

Lumbar Expandable lnterbody Spacers -Additional Indications/Implants is manufactured by Globus Medical, Inc..

What is the FDA product code for Lumbar Expandable lnterbody Spacers -Additional Indications/Implants?

The FDA product code for Lumbar Expandable lnterbody Spacers -Additional Indications/Implants is MAX.

Related Clinical Trials

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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

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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