Cleared Traditional

Hammertoe Truss System (HTS)

K190926 · 4Web, Inc. · Orthopedic
Jul 2019
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K190926 is an FDA 510(k) clearance for the Hammertoe Truss System (HTS), a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by 4Web, Inc. (Frisco, US). The FDA issued a Cleared decision on July 23, 2019, 105 days after receiving the submission on April 9, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K190926 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2019
Decision Date July 23, 2019
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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