Cleared Traditional

PIONEER LATERAL PLATE SYSTEM

K120724 · Pioneer Surgical Technology, Inc. · Orthopedic
May 2012
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K120724 is an FDA 510(k) clearance for the PIONEER LATERAL 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 May 7, 2012, 59 days after receiving the submission on March 9, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K120724 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2012
Decision Date May 07, 2012
Days to Decision 59 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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