Cleared Traditional

Cervical Plating System

K243369 · Life Spine, Inc. · Orthopedic
Dec 2024
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K243369 is an FDA 510(k) clearance for the Cervical Plating System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on December 11, 2024, 42 days after receiving the submission on October 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K243369 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2024
Decision Date December 11, 2024
Days to Decision 42 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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