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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K061151
Device Name PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
Applicant
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Applicant Contact JONATHAN M GILBERT
Correspondent
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Correspondent Contact JONATHAN M GILBERT
Regulation Number888.3060
Classification Product Code
MQP  
Date Received04/25/2006
Decision Date 07/24/2006
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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