Cleared Traditional

PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM

K130427 · Pioneer Surgical Technology, Inc. · Orthopedic
Jun 2013
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K130427 is an FDA 510(k) clearance for the PIONEER ASPECT 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 5, 2013, 105 days after receiving the submission on February 20, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K130427 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2013
Decision Date June 05, 2013
Days to Decision 105 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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