Cleared Traditional

Cannulated Screw System

K233396 · Smith & Nephew, Inc. · Orthopedic
Dec 2023
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K233396 is an FDA 510(k) clearance for the Cannulated Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on December 21, 2023, 79 days after receiving the submission on October 3, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K233396 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2023
Decision Date December 21, 2023
Days to Decision 79 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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