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FDA 510(k)

Catalyft™ LS Expandable Interbody System

K-Number: K241992 · 2024-10-28

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2024-10-28
Product CodeOVD
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 2024-10-28 under approval number K241992. The device is classified under product code OVD. 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 2024-10-28. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K241992.

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

Catalyft™ LS Expandable Interbody System received FDA 510(k) clearance on 2024-10-28, under approval number K241992.

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 OVD.

Related Clinical Trials

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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