FDA 510(k)

FORZA PTC Spacer System

N.º K: K152475 · 2016-01-14

Fecha de decisión2016-01-14

Código de productoMAX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

FORZA PTC Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K152475. 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 FORZA PTC Spacer System?

FORZA PTC Spacer System is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Orthofix, Inc.. The 510(k) number is K152475.

When did FORZA PTC Spacer System receive FDA 510(k) clearance?

FORZA PTC Spacer System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K152475.

Who is the listed applicant for FORZA PTC Spacer System?

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 FORZA PTC Spacer System?

The FDA product code for FORZA PTC Spacer System is MAX.

Ensayos clínicos relacionados

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Otros registros que enlistan a Orthofix, Inc. como solicitante

K240749PILLAR SA Ti Spacer System (82-XXX)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

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Dispositivos relacionados (Código: MAX)

Fuente oficial

Ver en la base de datos de la FDA →

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