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FDA 510(k)

PSX Interbody System

K-Number: K211873 · 2021-08-10

ApplicantAlphatec Spine, Inc.
Decision Date2021-08-10
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PSX Interbody System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2021-08-10 under approval number K211873. 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 PSX Interbody System?

PSX Interbody System is a medical device that received FDA 510(k) clearance on 2021-08-10. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K211873.

When was PSX Interbody System approved by the FDA?

PSX Interbody System received FDA 510(k) clearance on 2021-08-10, under approval number K211873.

What company makes PSX Interbody System?

PSX Interbody System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for PSX Interbody System?

The FDA product code for PSX Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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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