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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 K153735
Device Name Release Laminoplasty Fixation System
Applicant
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
375 River Park Circle
Marquette,  MI  49855
Applicant Contact Sarah Pleaugh
Correspondent
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
375 River Park Circle
Marquette,  MI  49855
Correspondent Contact Sarah Pleaugh
Regulation Number888.3050
Classification Product Code
NQW  
Date Received12/28/2015
Decision Date 01/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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