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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 Ct.
Allendale,  NJ  07401
Applicant Contact GARRY T HAYECK
Correspondent
Stryker Corporation
2 Pearl Ct.
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
Predetermined Change
Control Plan Authorized		 No
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