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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 intervertebral body
510(k) Number K183060
Device Name CervAlign™ Anterior Cervical Plate System
Applicant
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
375 River Park Circle
Marquette,  MI  49855
Applicant Contact Jaclyn Holli
Correspondent
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
375 River Park Circle
Marquette,  MI  49855
Correspondent Contact Jaclyn Holli
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/02/2018
Decision Date 01/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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