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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 K093692
Device Name QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
Applicant
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Applicant Contact EMILY M DOWNS
Correspondent
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Correspondent Contact EMILY M DOWNS
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWQ   MNH   MNI  
Date Received11/30/2009
Decision Date 08/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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