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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K102903
Device Name PIONEER CANNULATED SCREW SYSTEM
Applicant
Pioneer Surgical Technology, Inc.
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact EMILY M DOWNS
Correspondent
Pioneer Surgical Technology, Inc.
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact EMILY M DOWNS
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
OUR  
Date Received09/30/2010
Decision Date 10/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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