Cleared Traditional

ATEC Lateral Plate System

K230721 · Alphatec Spine, Inc. · Orthopedic
May 2023
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K230721 is an FDA 510(k) clearance for the ATEC Lateral Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 9, 2023, 55 days after receiving the submission on March 15, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K230721 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2023
Decision Date May 09, 2023
Days to Decision 55 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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