Cleared Traditional

PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM

K121725 · Pioneer Surgical Technology, Inc. · Orthopedic
Nov 2012
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K121725 is an FDA 510(k) clearance for the PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) 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 November 7, 2012, 148 days after receiving the submission on June 12, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K121725 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2012
Decision Date November 07, 2012
Days to Decision 148 days
Submission Type Traditional
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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