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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 K171031
Device Name CRESCENT™ Spinal System
Applicant
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact Ankit K. Shah
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact Ankit K. Shah
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/06/2017
Decision Date 07/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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