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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 K111528
Device Name PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
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 Number888.3060
Classification Product Code
KWQ  
Date Received06/02/2011
Decision Date 08/24/2011
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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