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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
Recalls CDRH Recalls
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