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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, spinal pedicle fixation, for degenerative disc disease
510(k) Number K111502
Model 01-SERIES; 10-SERIES
Device Name STREAMLINE TL SPINAL SYSTEM
Original Applicant
PIONEER SURGICAL TECHNOLOGY, INC
375 river park circle
marquette,  MI  49855
Original Contact sarah mcintyre
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received05/31/2011
Decision Date 08/23/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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