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FDA 510(k)

EVOS Cabling System

K-Number: K201497 · 2020-10-28

ApplicantPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Decision Date2020-10-28
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOS Cabling System is a medical device manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2020-10-28 under approval number K201497. 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 EVOS Cabling System?

EVOS Cabling System is a medical device that received FDA 510(k) clearance on 2020-10-28. It is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K201497.

When was EVOS Cabling System approved by the FDA?

EVOS Cabling System received FDA 510(k) clearance on 2020-10-28, under approval number K201497.

What company makes EVOS Cabling System?

EVOS Cabling System is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.).

What is the FDA product code for EVOS Cabling System?

The FDA product code for EVOS Cabling System is JDQ.

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

K161498Streamline OCT Occipito-Cervico-Thoracic System K153735Release Laminoplasty Fixation System K172139Streamline OCT Occipito-Cervico-Thoracic System K183060CervAlign™ Anterior Cervical Plate System K193468Tritium Sternal Cable Plate System K192800Streamline TL Spinal Fixation System

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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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