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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 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.

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. 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.

Other records listing Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. as applicant

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K201497EVOS Cabling SystemK200513DAC Dynamic Active Compression PlateK200095Streamline Navigated InstrumentsK193468Tritium Sternal Cable Plate SystemK192800Streamline TL Spinal Fixation SystemK192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology

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Related Devices (Code: JDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.

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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