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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 K143163
Device Name AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System
Applicant
STRYKER CORPORATION
2 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact GARRY T HAYECK
Correspondent
STRYKER CORPORATION
2 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact GARRY T HAYECK
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MAX  
Date Received11/03/2014
Decision Date 01/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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