Cleared Traditional

K233949 - ACCORD Cable System (FDA 510(k) Clearance)

K233949 · Smith & Nephew, Inc. · Orthopedic device

Mar 2024

Decision

90d

Days

Class 2

Risk

K233949 is an FDA 510(k) clearance for the ACCORD Cable System. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).

Submitted by Smith & Nephew, Inc. (Memphis, 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 FDA review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K233949 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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