FDA 510(k)

Tritium Sternal Cable Plate System

N.º K: K193468 · 2020-03-12

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

Fecha de decisión2020-03-12

Código de productoJDQ

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tritium Sternal Cable Plate 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 2020-03-12 under 510(k) number K193468. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Tritium Sternal Cable Plate System?

Tritium Sternal Cable Plate System is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K193468.

When did Tritium Sternal Cable Plate System receive FDA 510(k) clearance?

Tritium Sternal Cable Plate System received FDA 510(k) clearance on 2020-03-12, under 510(k) number K193468.

Who is the listed applicant for Tritium Sternal Cable Plate 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 Tritium Sternal Cable Plate System?

The FDA product code for Tritium Sternal Cable Plate System is JDQ.

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Dispositivos relacionados (Código: JDQ)

K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.K243344Arthrex FiberTape y TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.K232733Mbrace CableMedacta International S.A.K233949ACCORD Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.

Fuente oficial

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