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FDA 510(k)

Tritium Sternal Cable Plate System

K-Number: K193468 · 2020-03-12

ApplicantPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Decision Date2020-03-12
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 2020-03-12 under approval number K193468. 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 2020-03-12. It is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K193468.

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

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

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.

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

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Related Devices (Code: JDQ)

K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. 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

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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