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FDA 510(k)

Tritium® Sternal Cable Plate System

K-Number: K161876 · 2016-09-09

ApplicantPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Decision Date2016-09-09
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tritium® Sternal Cable Plate System is a medical device manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. It received FDA 510(k) clearance on 2016-09-09 under approval number K161876. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K161876.

When was Tritium® Sternal Cable Plate System approved by the FDA?

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

What company makes Tritium® Sternal Cable Plate System?

Tritium® Sternal Cable Plate System is manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc..

What is the FDA product code for Tritium® Sternal Cable Plate System?

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

Related Clinical Trials

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Other Devices by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

K152793Unison-C Anterior Cervical Fixation System K170830Unison-C Anterior Cervical 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 K200095Streamline Navigated Instruments

Related Devices (Code: JDQ)

K151983KLS Martin LSS Plating SystemKLS Martin L.P. K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc. K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. K170206Arthrex FiberTape CerclageArthrex, Inc. K181607Thorecon Rigid Fixation SystemA & E Medical Corporation K173910Impress SFS SystemCable Fix Medical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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