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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 K132738
Device Name COGENT MED-LIF
Applicant
Cogent Spine, LLC
101 N. Acacia Ave., Suite 106
Solana Beach,  CA  92075
Applicant Contact JUDE PAGANELLI
Correspondent
Cogent Spine, LLC
101 N. Acacia Ave., Suite 106
Solana Beach,  CA  92075
Correspondent Contact JUDE PAGANELLI
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/03/2013
Decision Date 04/15/2014
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
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