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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 K140303
Device Name ALAMO T
Applicant
Alliance Partners, LLC
4600 E Shelby Dr.
Memphis,  TN  38118
Applicant Contact KELLEN HILLS
Correspondent
Alliance Partners, LLC
4600 E Shelby Dr.
Memphis,  TN  38118
Correspondent Contact KELLEN HILLS
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/06/2014
Decision Date 04/21/2014
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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