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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
Device Name PIONEER STERNAL CABLE PLATE SYSTEM
Applicant
Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette,  MI  49855
Applicant Contact SARAH MCINTYRE
Correspondent
Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette,  MI  49855
Correspondent 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 (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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