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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 K143616
Device Name AccuLIF TL and PL Cage
Applicant
STRYKER CORPORATION
2 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact Aakash Jain
Correspondent
STRYKER CORPORATION
2 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact Aakash Jain
Regulation Number888.3080
Classification Product Code
MAX  
Date Received12/19/2014
Decision Date 03/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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