Cleared Special

Release Laminoplasty Fixation System

K153735 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic

Jan 2016

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K153735 is an FDA 510(k) clearance for the Release Laminoplasty Fixation System, a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II — Special Controls, product code NQW), submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on January 21, 2016, 24 days after receiving the submission on December 28, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K153735 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2015
Decision Date	January 21, 2016
Days to Decision	24 days
Submission Type	Special
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.