Cleared Special

STREAMLINE TL SPINAL FIXATION SYSTEM

K140696 · Pioneer Surgical Technology, Inc. · Orthopedic

Apr 2014

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K140696 is an FDA 510(k) clearance for the STREAMLINE TL 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 10, 2014, 22 days after receiving the submission on March 19, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K140696 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 2014
Decision Date	April 10, 2014
Days to Decision	22 days
Submission Type	Special
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.