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FDA 510(k)

SABLE Expandable Spacer

K-Number: K192115 · 2020-01-14

ApplicantGlobus Medical, Inc.
Decision Date2020-01-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SABLE Expandable Spacer is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2020-01-14 under approval number K192115. 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 SABLE Expandable Spacer?

SABLE Expandable Spacer is a medical device that received FDA 510(k) clearance on 2020-01-14. It is manufactured by Globus Medical, Inc.. The 510(k) number is K192115.

When was SABLE Expandable Spacer approved by the FDA?

SABLE Expandable Spacer received FDA 510(k) clearance on 2020-01-14, under approval number K192115.

What company makes SABLE Expandable Spacer?

SABLE Expandable Spacer is manufactured by Globus Medical, Inc..

What is the FDA product code for SABLE Expandable Spacer?

The FDA product code for SABLE Expandable Spacer 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

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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