Cleared Traditional

PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM

K113218 · Pioneer Surgical Technology, Inc. · Orthopedic

Jan 2012

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K113218 is an FDA 510(k) clearance for the PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM, a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II — Special Controls, product code NQW), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on January 26, 2012, 86 days after receiving the submission on November 1, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K113218 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2011
Decision Date	January 26, 2012
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NQW — Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3050
Definition	This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.