Cleared Traditional

Quantum Anterior Cervical Plate

K210424 · Nvision Biomedical Technologies, Inc. · Orthopedic
Oct 2021
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K210424 is an FDA 510(k) clearance for the Quantum Anterior Cervical Plate, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Nvision Biomedical Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on October 22, 2021, 253 days after receiving the submission on February 11, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K210424 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2021
Decision Date October 22, 2021
Days to Decision 253 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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