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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, cervical
510(k) Number K111264
Device Name CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
Applicant
MEDTRONIC SOFAMOR DANEK USA
1800 pyramid place
memphis,  TN  38132
Applicant Contact regina holmes
Correspondent
MEDTRONIC SOFAMOR DANEK USA
1800 pyramid place
memphis,  TN  38132
Correspondent Contact regina holmes
Regulation Number888.3080
Classification Product Code
ODP  
Date Received05/04/2011
Decision Date 10/12/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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