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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 K152793
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 EMILY ROBERGE
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact KENNETH C MAXWELL II
Regulation Number888.3080
Classification Product Code
OVE  
Date Received09/28/2015
Decision Date 01/19/2016
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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