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FDA 510(k)

Catalyft PL Expandable Interbody System

K-Number: K253011 · 2026-07-17

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2026-07-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Catalyft PL 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 2026-07-17 under 510(k) number K253011. 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 2026-07-17. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K253011.

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

Catalyft PL Expandable Interbody System received FDA 510(k) clearance on 2026-07-17, under 510(k) number K253011.

Who is the listed applicant for Catalyft PL 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 PL Expandable Interbody System?

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

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

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Related Devices (Code: MAX)

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.

K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, 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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