Cleared Traditional

TRIGEN META-NAIL Nail System

K230761 · Smith & Nephew, Inc. · Orthopedic
Jun 2023
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K230761 is an FDA 510(k) clearance for the TRIGEN META-NAIL Nail System, 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 14, 2023, 86 days after receiving the submission on March 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K230761 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2023
Decision Date June 14, 2023
Days to Decision 86 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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