Cleared Traditional

ADIRA? Lateral Plate System

K233735 · Globus Medical, Inc. · Orthopedic
Jan 2024
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K233735 is an FDA 510(k) clearance for the ADIRA? Lateral Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on January 25, 2024, 64 days after receiving the submission on November 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K233735 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2023
Decision Date January 25, 2024
Days to Decision 64 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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