FDA 510(k)

Streamline TL Spinal Fixation System

N.º K: K192800 · 2020-01-14

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

Fecha de decisión2020-01-14

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Streamline TL Spinal 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 2020-01-14 under 510(k) number K192800. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Streamline TL Spinal Fixation System?

Streamline TL Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K192800.

When did Streamline TL Spinal Fixation System receive FDA 510(k) clearance?

Streamline TL Spinal Fixation System received FDA 510(k) clearance on 2020-01-14, under 510(k) number K192800.

Who is the listed applicant for Streamline TL Spinal 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 Streamline TL Spinal Fixation System?

The FDA product code for Streamline TL Spinal Fixation System is NKB.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 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 K183060CervAlign™ Anterior Cervical Plate System

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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.