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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K122293
Model 86-SERIES
Device Name PIONEER STERNAL CABLE PLATE SYSTEM
Original Applicant
PIONEER SURGICAL TECHNOLOGY, INC
375 river park circle
marquette,  MI  49855
Original Contact sarah mcintyre
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDQ  
Date Received07/31/2012
Decision Date 10/12/2012
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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