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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K141993
Device Name NAKOMA ACP
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 Number888.3060
Classification Product Code
KWQ  
Date Received07/22/2014
Decision Date 11/06/2014
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
Recalls CDRH Recalls
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