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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 K103731
Device Name CAPSTONE R SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact THAO PHAN
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact THAO PHAN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/22/2010
Decision Date 07/18/2011
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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