Cleared Traditional

TRIGEN Stable Lock Nut & Washer

K243608 · Smith & Nephew, Inc. · Orthopedic
Jun 2025
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K243608 is an FDA 510(k) clearance for the TRIGEN Stable Lock Nut & Washer, a Nail, Fixation, Bone (Class II — Special Controls, product code JDS), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on June 12, 2025, 202 days after receiving the submission on November 22, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243608 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2024
Decision Date June 12, 2025
Days to Decision 202 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDS — Nail, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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