FDA 510(k)

PILLAR SA Ti Spacer System (82-XXX)

N.º K: K240749 · 2024-05-28

Fecha de decisión2024-05-28

Código de productoMAX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

PILLAR SA Ti Spacer System (82-XXX) is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K240749. 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 PILLAR SA Ti Spacer System (82-XXX)?

PILLAR SA Ti Spacer System (82-XXX) is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Orthofix, Inc.. The 510(k) number is K240749.

When did PILLAR SA Ti Spacer System (82-XXX) receive FDA 510(k) clearance?

PILLAR SA Ti Spacer System (82-XXX) received FDA 510(k) clearance on 2024-05-28, under 510(k) number K240749.

Who is the listed applicant for PILLAR SA Ti Spacer System (82-XXX)?

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

What is the FDA product code for PILLAR SA Ti Spacer System (82-XXX)?

The FDA product code for PILLAR SA Ti Spacer System (82-XXX) is MAX.

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Otros registros que enlistan a Orthofix, Inc. como solicitante

K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System K210667FIREBIRD SI Fusion System K203342CONSTRUX Mini Ti Spacer System K203576FORZA Ti Spacer System K203138FIREBIRD SI Fusion System

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Dispositivos relacionados (Código: MAX)

Fuente oficial

Ver en la base de datos de la FDA →

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