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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 Interlaminal
510(k) Number K101525
Device Name PIONEER SPINOUS PROCESS FUSION PLATE
Applicant
Pioneer Surgical Technology
5 Hemingway Lane
West Newbury,  MA  01985
Applicant Contact BARRY E SANDS
Correspondent
Pioneer Surgical Technology
5 Hemingway Lane
West Newbury,  MA  01985
Correspondent Contact BARRY E SANDS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received06/02/2010
Decision Date 10/22/2010
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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