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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 K110692
Device Name STREAMLINE TL SPINAL SYSTEM
Applicant
Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette,  MI  49855
Applicant Contact EMILY M DOWNS
Correspondent
Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette,  MI  49855
Correspondent Contact EMILY M DOWNS
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received03/11/2011
Decision Date 05/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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