FDA 510(k)

Catalyft PL Expandable Interbody System

N.º K: K253011 · 2026-07-17

SolicitanteMedtronic Sofamor Danek USA, Inc.

Fecha de decisión2026-07-17

Código de productoMAX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a Medtronic Sofamor Danek USA, Inc. como solicitante

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Dispositivos relacionados (Código: MAX)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Sistema Admiral ACP; Sistema Explorer TO; Sistema de Laminoplastia; Espaciador TDF Manta Ray; Sistema Interbody Meridian; Sistema de Placa Anterior Meridian; Sistema Interbody L Reef; Sistema TO/TA Reef; Sistema Lateral Regatta; Sistema de Placa Lateral Regatta; Sistema Interbody ACS Shoreline; Placa TruProfile Entornada Shoreline; Sistema Interbody RT Shoreline; Malla Vu; Sistema Interbody A WaveForm; Sistema Interbody C WaveForm; Sistema Interbody L WaveForm; Sistema Interbody TA WaveForm; Sistema Interbody TO WaveFormSeaSpine Orthopedics Corporation K253151Sistema de Caja de Fusion Interbody FuleBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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