Cleared Special

PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES

K111528 · Pioneer Surgical Technology, Inc. · Orthopedic
Aug 2011
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K111528 is an FDA 510(k) clearance for the PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES, 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 August 24, 2011, 83 days after receiving the submission on June 2, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K111528 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2011
Decision Date August 24, 2011
Days to Decision 83 days
Submission Type Special
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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