Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Arthrex Radiopaque FiberTape Cerclage sutures

K-Number: K230976 · 2023-08-24

ApplicantArthrex, Inc.
Decision Date2023-08-24
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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 2023-08-24 under 510(k) number K230976. 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 Radiopaque FiberTape Cerclage sutures?

Arthrex Radiopaque FiberTape Cerclage sutures is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Arthrex, Inc.. The 510(k) number is K230976.

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

Arthrex Radiopaque FiberTape Cerclage sutures received FDA 510(k) clearance on 2023-08-24, under 510(k) number K230976.

Who is the listed applicant for 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 Radiopaque FiberTape Cerclage sutures?

The FDA product code for Arthrex Radiopaque FiberTape Cerclage sutures 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

View all 173 devices →

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.

↑