Cleared Special

PIONEER POSTERIOR CERVICO THORACIC SYSTEM

K112757 · Pioneer Surgical Technology, Inc. · Orthopedic
Mar 2012
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K112757 is an FDA 510(k) clearance for the PIONEER POSTERIOR CERVICO THORACIC SYSTEM, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on March 12, 2012, 172 days after receiving the submission on September 22, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K112757 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2011
Decision Date March 12, 2012
Days to Decision 172 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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