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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K192800
Device Name Streamline TL Spinal Fixation System
Applicant
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
375 River Park Circle
Marquette,  MI  49855
Applicant Contact Kurtis Hunsberger
Correspondent
MCRA, LLC
1050 K Street NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
KWP  
Date Received09/30/2019
Decision Date 01/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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