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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 K133374
Device Name STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
Applicant
Pioneer Surgical Technology, Inc. (Rti Surgical, I
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact SARAH MCINTYRE
Correspondent
Pioneer Surgical Technology, Inc. (Rti Surgical, I
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact SARAH MCINTYRE
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/01/2013
Decision Date 03/19/2014
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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