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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 Integrated Fixation, Lumbar
510(k) Number K133827
Device Name A-LINK Z
Applicant
Osteo Vasive, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Applicant Contact KEVIN A THOMAS
Correspondent
Osteo Vasive, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number888.3080
Classification Product Code
OVD  
Date Received12/17/2013
Decision Date 11/17/2014
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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