Cleared Traditional

CervAlign? Anterior Cervical Plate System

K183060 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic
Jan 2019
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K183060 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. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on January 17, 2019, 76 days after receiving the submission on November 2, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K183060 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2018
Decision Date January 17, 2019
Days to Decision 76 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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