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FDA 510(k)

XYcor® Expandable Spinal Spacer System

K-Number: K160646 · 2016-08-24

ApplicantAlphatec Spine, Inc.
Decision Date2016-08-24
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XYcor® Expandable Spinal Spacer System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2016-08-24 under approval number K160646. 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 XYcor® Expandable Spinal Spacer System?

XYcor® Expandable Spinal Spacer System is a medical device that received FDA 510(k) clearance on 2016-08-24. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K160646.

When was XYcor® Expandable Spinal Spacer System approved by the FDA?

XYcor® Expandable Spinal Spacer System received FDA 510(k) clearance on 2016-08-24, under approval number K160646.

What company makes XYcor® Expandable Spinal Spacer System?

XYcor® Expandable Spinal Spacer System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for XYcor® Expandable Spinal Spacer System?

The FDA product code for XYcor® Expandable Spinal Spacer System is MAX.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Alphatec Spine, Inc.

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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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