Cleared Traditional

Lumbar Spine Truss System Plating Solution (LSTS-PS)

K203065 · 4Web, Inc. · Orthopedic
Mar 2021
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K203065 is an FDA 510(k) clearance for the Lumbar Spine Truss System Plating Solution (LSTS-PS), a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by 4Web, Inc. (Frisco, US). The FDA issued a Cleared decision on March 10, 2021, 152 days after receiving the submission on October 9, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K203065 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 2020
Decision Date March 10, 2021
Days to Decision 152 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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