Cleared Traditional

Osteotomy Truss System (OTS)

K172294 · 4Web, Inc. · Orthopedic
Feb 2018
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K172294 is an FDA 510(k) clearance for the Osteotomy Truss System (OTS), a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by 4Web, Inc. (Frisco, US). The FDA issued a Cleared decision on February 22, 2018, 206 days after receiving the submission on July 31, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K172294 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2017
Decision Date February 22, 2018
Days to Decision 206 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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