FDA 510(k)

Impress SFS System

K-Number: K173910 · 2018-09-14

Decision Date2018-09-14

Product CodeJDQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Impress SFS System is a medical device manufactured by Cable Fix Medical, LLC. It received FDA 510(k) clearance on 2018-09-14 under approval number K173910. 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 Impress SFS System?

Impress SFS System is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Cable Fix Medical, LLC. The 510(k) number is K173910.

When was Impress SFS System approved by the FDA?

Impress SFS System received FDA 510(k) clearance on 2018-09-14, under approval number K173910.

What company makes Impress SFS System?

Impress SFS System is manufactured by Cable Fix Medical, LLC.

What is the FDA product code for Impress SFS System?

The FDA product code for Impress SFS System is JDQ.

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

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