Cleared Traditional

CervAlign? Anterior Cervical Plate System

K211408 · Pioneer Surgical Technology, Inc. · Orthopedic
Jun 2021
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K211408 is an FDA 510(k) clearance for the CervAlign? Anterior Cervical Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on June 23, 2021, 48 days after receiving the submission on May 6, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K211408 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2021
Decision Date June 23, 2021
Days to Decision 48 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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