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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 bone graft, lumbar
510(k) Number K192502
Device Name Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion Sy
Applicant
Medtronic Sofamor Danek USA, Inc
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Emmarie Halteman
Correspondent
Medtronic Sofamor Danek USA, Inc
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Emmarie Halteman
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
KWQ   MQP   OVD   PLR  
Date Received09/12/2019
Decision Date 01/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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