FDA 510(k)

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

K-Nummer: K243344 · 2025-02-20

Entscheidungsdatum2025-02-20

ProduktcodeJDQ

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K243344. 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 Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures?

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Arthrex, Inc.. The 510(k) number is K243344.

When did Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures receive FDA 510(k) clearance?

Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures received FDA 510(k) clearance on 2025-02-20, under 510(k) number K243344.

Who is the listed applicant for Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures?

The FDA product code for Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures is JDQ.

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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.K232733Mbrace CableMedacta International S.A.K233949ACCORD Kabel-SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.

Offizielle Quelle

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