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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 K120401
Device Name ALAMO T
Applicant
Alliance Partners, LLC
33490 Pin Oak Pkwy.
Avon Lake,  OH  44012
Applicant Contact JENNIFER PALINCHIK
Correspondent
Alliance Partners, LLC
33490 Pin Oak Pkwy.
Avon Lake,  OH  44012
Correspondent Contact JENNIFER PALINCHIK
Regulation Number888.3080
Classification Product Code
MAX  
Date Received02/08/2012
Decision Date 10/05/2012
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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