Cleared Traditional

Osteotomy Truss System (OTS)

K240388 · 4Web Medical, Inc. · Orthopedic
Nov 2024
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K240388 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 Medical, Inc. (Frisco, US). The FDA issued a Cleared decision on November 1, 2024, 267 days after receiving the submission on February 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K240388 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2024
Decision Date November 01, 2024
Days to Decision 267 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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