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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 K140696
Device Name STREAMLINE TL SPINAL FIXATION SYSTEM
Applicant
PIONEER SURGICAL TECHNOLOGY, INC
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Applicant Contact SARAH MCINTYRE
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Correspondent Contact SARAH MCINTYRE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received03/19/2014
Decision Date 04/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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