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FDA 510(k)

Catalyft LS Expandable Interbody System

K-Number: K212653 · 2021-11-19

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2021-11-19
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyft LS Expandable Interbody System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2021-11-19 under approval number K212653. 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 LS Expandable Interbody System?

Catalyft LS Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2021-11-19. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K212653.

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

Catalyft LS Expandable Interbody System received FDA 510(k) clearance on 2021-11-19, under approval number K212653.

What company makes Catalyft LS Expandable Interbody System?

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

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

The FDA product code for Catalyft LS Expandable 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 NCT07082426 Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study ACTIVE_NOT_RECRUITING

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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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