FDA 510(k)

Tritium® Sternal Cable Plate System

K-Nummer: K161876 · 2016-09-09

AntragstellerPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

Entscheidungsdatum2016-09-09

ProduktcodeJDQ

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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 2016-09-09 under 510(k) number K161876. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Tritium® Sternal Cable Plate System?

Tritium® Sternal Cable Plate System is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K161876.

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

Tritium® Sternal Cable Plate System received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161876.

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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

Weitere Einträge mit Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. als Antragsteller

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

Alle 13 Geräte anzeigen →

Verwandte Geräte (Code: JDQ)

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

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.