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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 K100708
Device Name PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
Applicant
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Applicant Contact EMILY M DOWNS
Correspondent
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Correspondent Contact EMILY M DOWNS
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/12/2010
Decision Date 06/04/2010
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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