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FDA 510(k)

Arthrex FiberTape Cerclage

K-Number: K170206 · 2017-11-15

ApplicantArthrex, Inc.
Decision Date2017-11-15
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex FiberTape Cerclage is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2017-11-15 under 510(k) number K170206. 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 Arthrex FiberTape Cerclage?

Arthrex FiberTape Cerclage is a medical device that received FDA 510(k) clearance on 2017-11-15. The listed applicant is Arthrex, Inc.. The 510(k) number is K170206.

When did Arthrex FiberTape Cerclage receive FDA 510(k) clearance?

Arthrex FiberTape Cerclage received FDA 510(k) clearance on 2017-11-15, under 510(k) number K170206.

Who is the listed applicant for Arthrex FiberTape Cerclage?

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 Cerclage?

The FDA product code for Arthrex FiberTape Cerclage is JDQ.

Other records listing Arthrex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsK260624Arthrex Radial Head Replacement SystemK260018Arthrex FiberButtonK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemK253931Arthrex Bioabsorbable PushLock Suture AnchorsK254215Arthrex Beaming System

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Related Devices (Code: JDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.

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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