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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2024-10-28 under 510(k) 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. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K241992.

When did Catalyft™ LS Expandable Interbody System receive FDA 510(k) clearance?

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

Who is the listed applicant for Catalyft™ LS Expandable Interbody System?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Catalyft™ LS Expandable Interbody System is OVD.

Other records listing Medtronic Sofamor Danek USA, Inc. as applicant

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Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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