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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K170830
Device Name Unison-C Anterior Cervical Fixation System
Applicant
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact Sarah Pleaugh
Correspondent
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact Sarah Pleaugh
Regulation Number888.3080
Classification Product Code
OVE  
Date Received03/20/2017
Decision Date 06/28/2017
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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