Cleared Traditional

ACCORD Cable System

K233949 · Smith & Nephew, Inc. · Orthopedic
Mar 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K233949 is an FDA 510(k) clearance for the ACCORD Cable System, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on March 13, 2024, 90 days after receiving the submission on December 14, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K233949 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2023
Decision Date March 13, 2024
Days to Decision 90 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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