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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spine, Plate, Laminoplasty, Metal
510(k) Number K113218
Device Name PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
Applicant
Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette,  MI  49855
Applicant Contact SARAH MCLNTYRE
Correspondent
Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette,  MI  49855
Correspondent Contact SARAH MCLNTYRE
Regulation Number888.3050
Classification Product Code
NQW  
Date Received11/01/2011
Decision Date 01/26/2012
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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