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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K120724
Model 38-SERIES
Device Name PIONEER LATERAL PLATE SYSTEM
Original Applicant
PIONEER SURGICAL TECHNOLOGY, INC
375 river park circle
marquette,  MI  49855
Original Contact sarah mcintyre
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/09/2012
Decision Date 05/07/2012
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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