Cleared Traditional

Arthrex Radiopaque FiberTape Cerclage sutures

K230976 · Arthrex, Inc. · Orthopedic
Aug 2023
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K230976 is an FDA 510(k) clearance for the Arthrex Radiopaque FiberTape Cerclage sutures, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 24, 2023, 141 days after receiving the submission on April 5, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K230976 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2023
Decision Date August 24, 2023
Days to Decision 141 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDQ — Cerclage, Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3010

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