Cleared Traditional

Double ENDOBUTTON Fixation Device

K183232 · Smith and Nephew, Inc. · Orthopedic
Mar 2019
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K183232 is an FDA 510(k) clearance for the Double ENDOBUTTON Fixation Device, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Smith and Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on March 12, 2019, 112 days after receiving the submission on November 20, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K183232 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2018
Decision Date March 12, 2019
Days to Decision 112 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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