Cleared Special

Extended HA Half Pins

K210784 · Smith & Nephew, Inc. · Orthopedic
Apr 2021
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K210784 is an FDA 510(k) clearance for the Extended HA Half Pins, a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on April 2, 2021, 17 days after receiving the submission on March 16, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K210784 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2021
Decision Date April 02, 2021
Days to Decision 17 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDW — Pin, Fixation, Threaded
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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