Cleared Traditional

Streamline TL Spinal Fixation System

K192800 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic

Jan 2020

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K192800 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. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on January 14, 2020, 106 days after receiving the submission on September 30, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K192800 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2019
Decision Date	January 14, 2020
Days to Decision	106 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.