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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 K092295
Device Name PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
Applicant
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact EMILY M DOWNS
Correspondent
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact EMILY M DOWNS
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received07/29/2009
Decision Date 02/19/2010
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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