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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 K110562
Device Name TELAMON PEEK SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek USA
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact REGINA HOLMES
Correspondent
Medtronic Sofamor Danek USA
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact REGINA HOLMES
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/28/2011
Decision Date 11/09/2011
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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