Cleared Traditional

STREAMLINE MIS SPINAL FIXATION SYSTEM

K130286 · Pioneer Surgical Technology, Inc. · Orthopedic

Apr 2013

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K130286 is an FDA 510(k) clearance for the STREAMLINE MIS SPINAL FIXATION SYSTEM, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on April 1, 2013, 55 days after receiving the submission on February 5, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K130286 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2013
Decision Date	April 01, 2013
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.