FDA 510(k)

Release Laminoplasty Fixation System

N.º K: K153735 · 2016-01-21

SolicitantePioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Fecha de decisión2016-01-21

Código de productoNQW

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Release Laminoplasty Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K153735. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Release Laminoplasty Fixation System?

Release Laminoplasty Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K153735.

When did Release Laminoplasty Fixation System receive FDA 510(k) clearance?

Release Laminoplasty Fixation System received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153735.

Who is the listed applicant for Release Laminoplasty Fixation System?

The FDA 510(k) record lists Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Release Laminoplasty Fixation System?

The FDA product code for Release Laminoplasty Fixation System is NQW.

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Otros registros que enlistan a Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) como solicitante

K201497EVOS Cabling System K200095Streamline Navigated Instruments K193468Tritium Sternal Cable Plate System K192800Streamline TL Spinal Fixation System K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System

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Dispositivos relacionados (Código: NQW)

K252930Sistemas de laminoplastia AQUAZheJiang Decans Medical Devices Co., Ltd.K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC K231232Curiteva Laminoplasty SystemCuriteva, Inc.K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.