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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 K150254
Device Name Streamline OCT Occipito-Cervico-Thoracic 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
KWP  
Date Received02/03/2015
Decision Date 04/28/2015
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
Recalls CDRH Recalls
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