Streamline TL Spinal Fixation System

Thoracolumbosacral Pedicle Screw System

Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) with the FDA for Streamline Tl Spinal Fixation System.

Pre-market Notification Details

Device IDK192800
510k NumberK192800
Device Name:Streamline TL Spinal Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) 375 River Park Circle Marquette,  MI  49855
ContactKurtis Hunsberger
CorrespondentJustin Eggleton
MCRA, LLC 1050 K Street NW Suite 1000 Washington,  DC  20001
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-01-14

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