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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 K072703
Device Name PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
Applicant
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact JONATHAN M GILBERT
Correspondent
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact JONATHAN M GILBERT
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/24/2007
Decision Date 01/10/2008
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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