Cleared Traditional

STREAMLINE TL SPINAL SYSTEM

K111502 · Pioneer Surgical Technology, Inc. · Orthopedic

Aug 2011

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K111502 is an FDA 510(k) clearance for the STREAMLINE TL SPINAL 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 August 23, 2011, 84 days after receiving the submission on May 31, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K111502 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2011
Decision Date	August 23, 2011
Days to Decision	84 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.