Cleared Traditional

Smith & Nephew ACCORD? Cable System

K223762 · Smith & Nephew · Orthopedic
May 2023
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K223762 is an FDA 510(k) clearance for the Smith & Nephew ACCORD? Cable System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Smith & Nephew (Cordova, US). The FDA issued a Cleared decision on May 30, 2023, 166 days after receiving the submission on December 15, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K223762 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2022
Decision Date May 30, 2023
Days to Decision 166 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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