FDA 510(k)

Impress SFS System

K-Nummer: K173910 · 2018-09-14

Entscheidungsdatum2018-09-14

ProduktcodeJDQ

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Impress SFS System is the device name listed in this FDA 510(k) record. The listed applicant is Cable Fix Medical, LLC. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K173910. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Impress SFS System?

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

When did Impress SFS System receive FDA 510(k) clearance?

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

Who is the listed applicant for Impress SFS System?

The FDA 510(k) record lists Cable Fix Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Impress SFS System?

The FDA product code for Impress SFS System is JDQ.

Zugehörige klinische Studien

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Verwandte Geräte (Code: JDQ)

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 Kabel-SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.

Offizielle Quelle

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