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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 K160715
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 Tina Mornak
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/15/2016
Decision Date 07/08/2016
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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