FDA 510(k)

Catalyft PL Expandable Interbody System

K-Number: K210425 · 2021-05-24

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2021-05-24

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Catalyft PL Expandable Interbody System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2021-05-24 under approval number K210425. 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 Catalyft PL Expandable Interbody System?

Catalyft PL Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2021-05-24. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K210425.

When was Catalyft PL Expandable Interbody System approved by the FDA?

Catalyft PL Expandable Interbody System received FDA 510(k) clearance on 2021-05-24, under approval number K210425.

What company makes Catalyft PL Expandable Interbody System?

Catalyft PL Expandable Interbody System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for Catalyft PL Expandable Interbody System?

The FDA product code for Catalyft PL Expandable Interbody System is MAX.

Related Clinical Trials

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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.