Cleared Traditional

TRIGEN INTERTAN 10S Nail System

K241804 · Smith & Nephew, Inc. · Orthopedic
Aug 2024
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K241804 is an FDA 510(k) clearance for the TRIGEN INTERTAN 10S Nail System, a Nail, Fixation, Bone (Class II — Special Controls, product code JDS), submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on August 22, 2024, 62 days after receiving the submission on June 21, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K241804 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2024
Decision Date August 22, 2024
Days to Decision 62 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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